COVID-19Phase 1NCT04776317
Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic Vaccines Against SARS-CoV-2 in Healthy Adults
A Phase 1 study testing ChAdV68-S, ChAdV68-S-TCE and SAM-LNP-S in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized study of the safety, tolerability, and immunogenicity of investigational ChAd and SAM SARS-CoV-2 vaccines in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- ChAdV68-S, ChAdV68-S-TCE and SAM-LNP-S
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Mar 2021to 15 Sep 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects eligible to participate in this trial must meet all of the following inclusion criteria:
- Provide written informed consent prior to initiation of any study procedures
- Able and willing (in the investigator's opinion) to comply with all study requirements
- Are men or non-pregnant women aged 18 years or older at enrollment
- Are in good health*
- As defined by absence of clinically significant medical conditions defined by the CDC as increasing risk for severe corona virus disease-19 (COVID-19) (see exclusion criteria), or other acute or chronic medical conditions determined by medical history, physical examination (PE), screening laboratory test results, and/or clinical assessment of the investigator that are either listed as exclusion criteria below or in the opinion of the investigator would increase risk for study participation or affect the assessment of the safety of subjects. Chronic medical conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedures). Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the participating site PI or appropriate sub- investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. Similarly, medication changes in the 60 days prior to enrollment as well as subsequent to enrollment and study vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to study vaccination.
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- Agree to refrain from blood donation during the course of the study
- Plan to remain living in the area for the duration of the study
- Women of childbearing potential (WOCBP)* must plan to avoid pregnancy for at least 60 days after the last study vaccination and be willing to use an adequate method of contraception** consistently for 30 days prior to first study vaccine and for at least 60 days after the last study vaccine.
- Not sterilized via bilateral oophorectomy, tubal ligation/salpingectomy, hysterectomy, or successful Essure (R) placement (permanent, non-surgical, non-hormonal sterilization with documented radiological confirmation test at least 90 days after the procedure); still menstruating; or < 1 year has passed since the last menses if menopausal
- Acceptable methods of birth control include the following: oral contraceptives, injection hormonal contraceptive, implant hormonal contraceptive, hormonal patch, intrauterine device, spermicidal products and barrier methods (such as cervical sponge, diaphragm, or condom with spermicide), abstinence, monogamous with a vasectomized partner, non-male sexual relationship
- Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each study vaccination
- Vital signs within acceptable ranges:
- Pulse > 50 and = / < 100 beats per minute
- Systolic blood pressure (BP) = / < 140 millimeters of mercury (mmHg)
- Diastolic BP = / < 90 mmHg
- Oral temperature < 37.8 degrees Celsius (100.0 degrees Fahrenheit)
- Clinical screening lab evaluations (white blood cell (WBC), hemoglobin (HgB), platelets (PLT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (T Bili), creatine kinase (CK), serum creatinine (Cr) and prothrombin time (PT)/partial thromboplastin time (PTT)) are within acceptable normal reference ranges at the clinical lab being used* *With the exception that ALT, AST, ALP, and creatinine values that are below the reference range will not be exclusionary as these values below reference range are clinically insignificant. Any other screening lab value outside the reference range that is thought to be clinically insignificant by a site investigator must be discussed with the DMID Medical Officer prior to enrollment.
- Must agree to genetic testing and storage of samples for secondary research
- Received at least 2 doses of EUA/licensed mRNA vaccines or at least 1 dose of Ad26 vaccine followed by an mRNA booster, with the last COVID-19 vaccine dose given at least 112 days prior to enrollment (Stage 2 only), as confirmed via CDC vaccination card or other appropriate documentation. Subjects may or may not have been previously infected with SARS-CoV-2.
- A subject must meet all of the following criteria to be eligible for leukapheresis:
- Written informed consent for leukapheresis is provided
- Weight > / = 110 pounds
- Screening laboratory evaluations are within acceptable ranges at the site where the leukapheresis procedure will be performed
- Negative urine or serum pregnancy test at screening and on the day of the leukapheresis procedure for women of childbearing potential
- Adequate bilateral antecubital venous access
- No use of blood thinners, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) at least 5 days before the leukapheresis procedure
Who cannot join
- Subjects eligible to participate in this trial must not meet any of the following exclusion criteria:
- History of prior confirmed (PCR or antigen test positive) COVID-19 less than 112 days prior to enrollment.
- Positive for anti-nucleoprotein SARS-CoV-2 specific antibody by enzyme-linked immunosorbent assay (ELISA) and had the history of upper respiratory illness (URI) compatible with COVID-19 during the 112 days prior to enrollment (seropositivity without a history of URI during the 112 days prior to enrollment will be considered remotely infected persons eligible for enrollment).
- Positive nasal swab polymerase chain reaction (PCR) at screening.
- Body mass index (BMI) > 30 kg/m^2 for Stage 1 participants and BMI > 35 kg/m^2 for Stage 2 participants.
- Presence of medical comorbidities that would place the subject at increased risk for severe COVID-19*
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- Chronic kidney disease, chronic lung disease (including moderate-to-severe asthma), chronic heart disease (heart failure, coronary artery disease or cardiomyopathies), cerebrovascular disease, diabetes mellitus, chronic liver disease, sickle cell disease
- Increased risk of occupational exposure to SARS-CoV-2 (healthcare workers and emergency response personnel)*
- Applies to Stage 1 participants only
- Prior receipt of an approved/licensed or investigational SARS-CoV-2 vaccine (including under EUA)*, approved or investigational adenovirus-vectored vaccines**, or any other approved or investigational vaccine likely to impact the interpretation of the trial data.
- Exclusion of prior receipt of EUA/licensed COVID-19 vaccines applies to Stage 1 participants only.
- With the exception of prior receipt of EUA/licensed Johnson \& Johnson/Janssen Ad 26 COVID-19 vaccine which is permitted for Groups 8A, 8B, 12A, and 12B.
- On current treatment or prevention agents with activity against SARS-CoV-2
- Current smoking or vaping or history of smoking or vaping in prior year*
- Applies to Stage 1 participants only
- Breastfeeding, pregnant, or planning to become pregnant during the course of the study.
- Participation in another research study involving receipt of an investigational product in the 60 days preceding enrolment or planned use during the study period
- Receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination
- Receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of first study vaccination or at any time during the study
- Any confirmed or suspected immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic, and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the polyethylene glycol component of the vaccine)
- Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema
- Any history of anaphylaxis, including but not limited to reaction to vaccination
- Any history of severe allergic drug reaction
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation
- Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
- Bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture or family history of bleeding disorder
- Recent (within the past 3 months) surgery, immobility, chronic infection, or head trauma that could increase the risks of thrombosis.
- Suspected or known current alcohol abuse. Suspected or known drug abuse in the 5 years preceding enrollment
- Seropositive for HIV, hepatitis B surface antigen (HBsAg), or seropositive for hepatitis C virus (antibodies to HCV)
- Have an acute illness* within 72 hours prior to study vaccination
- An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol
- History of venous or arterial thrombosis or any known thrombophilic condition including heparin-induced thrombocytopenia (HIT) or family history of thrombosis.
- History of myocarditis or pericarditis.
- History of Guillain-Barre Syndrome (GBS).
- Receiving heparin treatment or on medications associated with increased risk of bleeding or thrombosis.
- Any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Hope Clinic of Emory University
Decatur, Georgia, 30030-1705
Baylor College of Medicine
Houston, Texas, 77030-3411
The University of Washington - Virology Research Clinic
Seattle, Washington, 98104
Saint Louis University Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
Official title: A Phase 1 Trial to Evaluate the Safety, Immunogenicity, and Reactogenicity of Heterologous and Homologous Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic Vaccines Against SARS-CoV-2 in Healthy Adults
This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized study of the safety, tolerability, and immunogenicity of investigational ChAd and SAM SARS-CoV-2 vaccines in healthy adult subjects. Homologous and heterologous prime-boost vaccination schedules (Stage 1), as well as boost(s) after receipt of COVID-19 EUA/licensed vaccines (Stage 2) will be examined. Subjects' willingness to receive ChAd vaccines will be assessed and documented at the time of informed consent and considered to determine group assignments. This phase 1 study will enroll 17 Stage 1 and up to 118 Stage 2 subjects. Eligible subjects will be enrolled in different groups based on their age (18-60 years old and >60 years old) and their EUA/licensed COVID-19 vaccination status. A sentinel approach with 72-hour (Stage 1, and Stage 2, Groups 5, 6, 8-10, 12, 13-15) or 7-day observation times (Groups 7 and 11) will be used, before recruiting the remainder of each dose escalation group. Decisions about dose escalation will be determined by the SSC with consultation with the DSMB as needed after all subjects in each group have been observed through Day 8 post first study vaccination. All subjects will be followed through 12 months after their last study vaccination. Vaccinated subjects will be carefully monitored for exposure and infection to SARS-CoV-2 throughout the study. Escalation to the highest dose (10 µg) of SAM-S-TCE in younger subjects will proceed only following safety assessments of the 10 µg dose in older subjects for a period of 28 days post-vaccination. In addition, the dosage of SAM-S-TCE given as a double boost to subjects previously vaccinated with the Johnson \& Johnson/Janssen Ad26 COVID-19 EUA/licensed vaccine in Groups 8A, 8B, and 12A, 12B will be determined based on the dose escalation reactogenicity and immunogenicity results in Groups 5-7 and 9-11, respectively. After protocol version 9.0 was implemented, it was decided not to enroll subjects into Groups 7 and 8 because of competing priorities and predicted difficulties enrolling into these two groups.
The primary objectives of this study are 1) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as prime-boost in healthy naïve adult subjects, 2) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as first or second boost in healthy adult subjects previously vaccinated with an mRNA or adenoviral-vectored COVID-19 EUA/licensed vaccine.
Read the detailed description
This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized study of the safety, tolerability, and immunogenicity of investigational ChAd and SAM SARS-CoV-2 vaccines in healthy adult subjects. Homologous and heterologous prime-boost vaccination schedules (Stage 1), as well as boost(s) after receipt of COVID-19 EUA/licensed vaccines (Stage 2) will be examined. Subjects' willingness to receive ChAd vaccines will be assessed and documented at the time of informed consent and considered to determine group assignments. This phase 1 study will enroll 17 Stage 1 and up to 118 Stage 2 subjects. Eligible subjects will be enrolled in different groups based on their age (18-60 years old and >60 years old) and their EUA/licensed COVID-19 vaccination status. A sentinel approach with 72-hour (Stage 1, and Stage 2, Groups 5, 6, 8-10, 12, 13-15) or 7-day observation times (Groups 7 and 11) will be used, before recruiting the remainder of each dose escalation group. Decisions about dose escalation will be determined by the SSC with consultation with the DSMB as needed after all subjects in each group have been observed through Day 8 post first study vaccination. All subjects will be followed through 12 months after their last study vaccination. Vaccinated subjects will be carefully monitored for exposure and infection to SARS-CoV-2 throughout the study. Escalation to the highest dose (10 µg) of SAM-S-TCE in younger subjects will proceed only following safety assessments of the 10 µg dose in older subjects for a period of 28 days post-vaccination. In addition, the dosage of SAM-S-TCE given as a double boost to subjects previously vaccinated with the Johnson \& Johnson/Janssen Ad26 COVID-19 EUA/licensed vaccine in Groups 8A, 8B, and 12A, 12B will be determined based on the dose escalation reactogenicity and immunogenicity results in Groups 5-7 and 9-11, respectively. After protocol version 9.0 was implemented, it was decided not to enroll subjects into Groups 7 and 8 because of competing priorities and predicted difficulties enrolling into these two groups.
The primary objectives of this study are 1) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as prime-boost in healthy naïve adult subjects, 2) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as first or second boost in healthy adult subjects previously vaccinated with an mRNA or adenoviral-vectored COVID-19 EUA/licensed vaccine. The secondary objective of this study is to assess the humoral immunogenicity of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE.
- Conditions
- COVID-19
- Being tested
- ChAdV68-S, ChAdV68-S-TCE, SAM-LNP-S, SAM-LNP-S-TCE, Sodium Chloride, 0.9%
- Keywords
- Immunogenicity, Prime-Boost, Reactogenicity, Safety, SARS-CoV-2, vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdV68-SBiological
Chimpanzee Adenovirus serotype 68 - Spike (ChAdV68-S) is a replication-defective, E1, E3 E4Orf2-4 deleted adenoviral vector based on chimpanzee adenovirus 68 (C68, 68/SAdV-25, originally designated as Pan 9), which belongs to the sub-group E adenovirus family. A single 0.5 mL intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
ChAdV68-S-TCEBiological
Chimpanzee Adenovirus 68 - Spike plus additional SARS-CoV-2 T cell epitopes (ChAdV68-S-TCE) is a replication-defective, E1, E3 E4Orf2-4 deleted adenoviral vector based on chimpanzee adenovirus 68 (C68, 68/SAdV-25, originally designated as Pan 9), which belongs to the sub-group E adenovirus family. A single 0.5- or 1.0-mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
SAM-LNP-SBiological
Self-Amplifying mRNA - Lipid Nanoparticles - Spike (SAM-LNP-S) is a SAM vector based on Venezuelan Equine Encephalitis Virus (VEEV). A single 0.25 mL or 0.5 mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
SAM-LNP-S-TCEBiological
Self-Amplifying mRNA - Lipid Nanoparticles -Spike plus additional SARS-CoV-2 T cell epitopes (SAM-S-TCE) is a SAM vector based on Venezuelan Equine Encephalitis Virus (VEEV). A single 0.25 or 0.5 mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
Sodium Chloride, 0.9%Other
The diluent used for this study will be 0.9% Sodium Chloride Injection, USP, and is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each milliliter (mL) contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Experimental | 5 x 10^10 viral particles of ChAdV68-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 29 in participants from 18 to 60 years of age. N=4 Receives: Biological: ChAdV68-S; Biological: SAM-LNP-S; Other: Sodium Chloride, 0.9% |
| Stage 1 (Naïve) Group 3A | Experimental | 30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 29 in participants from 18 to 60 years of age. N=3 Receives: Biological: SAM-LNP-S; Other: Sodium Chloride, 0.9% |
| Stage 1 (Naïve) Group 3B | Experimental | 30 mcg SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 3 mcg of SAM-LNP-S administered through 0.25 mL intramuscular injection in the deltoid muscle on or after Day 85 and no later than Day 130 in participants from 18 to 60 years of age. N=7 Receives: Biological: SAM-LNP-S; Other: Sodium Chloride, 0.9% |
| Stage 1 (Naïve) Group 4 | Experimental | 10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on or after Day 85 and no later than Day 130 in participants from 18 to 60 years of age. N=3 Receives: Biological: SAM-LNP-S-TCE; Other: Sodium Chloride, 0.9% |
| Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 13 | Experimental | 5 x 10^10 viral particles of ChAdV68-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and on or after Day 113 in participants older than 60 years of age. N=7-10 Receives: Biological: ChAdV68-S-TCE; Other: Sodium Chloride, 0.9% |
| Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 14 | Experimental | 1 x 10^11 viral particles of ChAdV68-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=7-10 Receives: Biological: ChAdV68-S-TCE; Other: Sodium Chloride, 0.9% |
| Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 15 | Experimental | 5 x 10^11 viral particles of ChAdV68-S-TCE administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=7-10 Receives: Biological: ChAdV68-S-TCE; Other: Sodium Chloride, 0.9% |
| Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 10A,B | Experimental | 6 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8-12 Receives: Biological: SAM-LNP-S-TCE |
| Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 11A,B | Experimental | 10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8-12 Receives: Biological: SAM-LNP-S-TCE |
| Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 12A,B | Experimental | 10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 10 mcg SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 57 in participants older than 60 years of age. N=8-12 Receives: Biological: SAM-LNP-S-TCE |
| Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 9 | Experimental | 3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8 Receives: Biological: SAM-LNP-S-TCE; Other: Sodium Chloride, 0.9% |
| Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 5 | Experimental | 3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=10 Receives: Biological: SAM-LNP-S-TCE; Other: Sodium Chloride, 0.9% |
| Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 6 | Experimental | 6 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=10 Receives: Biological: SAM-LNP-S-TCE; Other: Sodium Chloride, 0.9% |
| Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 7A,B | Experimental | 10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=8-12 Receives: Biological: SAM-LNP-S-TCE |
| Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 8A,B | Experimental | 10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 57 in participants from 18 to 60 years of age. N=8-12 Receives: Biological: SAM-LNP-S-TCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Number of participants that experienced any NOCMCs during the course of the study
Measured: Day 1 to study completion through up to 1 year post last dose
Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)
Number of participants that experienced any PIMMCs during the course of the study
Measured: Day 1 to study completion through up to 1 year post last dose
Frequency of Any Medically Attended Adverse Events (MAAEs)
Number of participants that experienced any MAAEs during the course of the study
Measured: Day 1 to study completion through up to 1 year post last dose
Frequency of Any Laboratory AE
Number of participants that experienced any laboratory AE
Measured: Through 7 days post each study vaccination
Frequency of Any Serious Adverse Events (SAEs)
The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Measured: Day 1 to study completion through up to 1 year post last dose
Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any systemic solicited AEs through 7 days post any vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever.
Measured: Day 1 through Day 8 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and through 7 days post any vaccination for Groups 1, 3A, 3b and 4.
Frequency of Local Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any local solicited AEs through 7 days post any vaccination. Local events include: pain at injection site, erythema, and induration.
Measured: Day 1 through Day 8 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and through 7 days post any vaccination for Groups 1, 3A, 3b and 4.
Frequency of Any Unsolicited Adverse Events (AEs)
Number of participants who experienced any unsolicited AEs through 28 days post vaccination
Measured: Day 1 through Day 29 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and 28 days post any vaccination for Groups 1, 3A, 3b and 4.
Secondary outcomes (130)
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Measured: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Measured: Day 57 Post Vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Measured: Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Measured: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Measured: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination 1 titer.
Measured: Day 169 Post Vac 1 (85 Days Post Vac 2), Day 265 Post Vac 1 (181 Days Post Vac 2), Day 450 Post Vac 1 (366 Days Post Vac 2)
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination titer.
Measured: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination titer.
Measured: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5. Fold-rise is calculated by dividing post-vaccination titers by the Day 1 Pre-Vaccination titer.
Measured: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1
Measured: Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5
Measured: Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5
Measured: Day 169 Post Vaccination 1 (85 Days Post Vaccination 2), Day 265 Post Vaccination 1 (181 Days Post Vaccination 2), Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A
Geometric Mean of RBD titer
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4
Geometric Mean of RBD titer
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of RBD titer
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A
Geometric Mean of S-2P titer
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4
Geometric Mean of S-2P titer
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Geometric Mean of S-2P titer
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G S-2P
Measured: Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.1 S-2P
Measured: Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3A
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against BA.4/5 S-2P
Measured: Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution) against D614G S-2P
Measured: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.1 S-2P
Measured: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.4/5 S-2P
Measured: Day 169 Post Vaccination 1 (85 Days Post Vaccination 2), Day 265 Post Vaccination 1 (181 Days Post Vaccination 2), Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against D614G S-2P
Measured: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.1 S-2P
Measured: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Participants Who Seroconverted, defined as a 4-fold change in Pseudovirus Neutralization ID50 (50% Inhibitory Dilution), against BA.4/5 S-2P
Measured: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Percent of CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Percent of CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Mean Percent of CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with Any COV2 S stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with Any TCE stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With G-Mem Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-Mem stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With G-Nuc Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-Nuc stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IFNg and/or IL-2 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IFNg and/or IL-2.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Percent of Responders: CD4+ T Cells With G-ORFa Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Percent of Responders: CD4+ T Cells with G-ORFa stimulation expressing IL-4 or IL-5 or IL-13 and CD154.
To assess positivity for a peptide pool within a T cell subset, a two-by-two contingency table was constructed comparing the stimulated and negative control data. The four entries in each table were the number of cells positive for the cytokine of interest and the number of cells negative for the cytokine, for both the stimulated and the negative control data. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the individual peptide pool p-vals using the Bonferroni-Holm adjustment method. If the adjusted p-val for a peptide pool was =0.00001, the response to the peptide pool for the T cell subset was considered positive.
Measured: Day 1 Pre-Vaccination, Day 15 Post Vaccination
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 1 and 3A
Mean spot forming units per million of the 15mer OLPs Spanning Membrane Frame as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 1 and 3A
Mean spot forming units per million of the 15mer OLPa Spanning Nucleocapsid Frame as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 1 and 3A
Mean spot forming units per million of the 15mer OLPs spanning Open Reading Frame 3a as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 1 and 3A
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 1 and 3A
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 1 and 3A
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 1 and 3A
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the S1 for Groups 1 and 3A
Mean spot forming units per million of the S1 as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the S2 for Groups 1 and 3A
Mean spot forming units per million of the S2 as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the Spike for Groups 1 and 3A
Mean spot forming units per million of the Spike as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 1 and 3A
Mean spot forming units per million of the 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 3B and 4
Mean spot forming units per million of the 15mer OLPs Spanning Membrane Frame as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 3B and 4
Mean spot forming units per million of the 15mer OLPa Spanning Nucleocapsid Frame as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 3B and 4
Mean spot forming units per million of the 15mer OLPs spanning Open Reading Frame 3a as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 3B and 4
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 3B and 4
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 3B and 4
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 3B and 4
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the S1 for Groups 3B and 4
Mean spot forming units per million of the S1 as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the S2 for Groups 3B and 4
Mean spot forming units per million of the S2 as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the Spike for Groups 3B and 4
Mean spot forming units per million of the Spike as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 3B and 4
Mean spot forming units per million of the 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a as measured by ELISpot
Measured: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Membrane Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the 15mer OLPs Spanning Membrane Frame as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the 15mer OLPa Spanning Nucleocapsid Frame for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the 15mer OLPa Spanning Nucleocapsid Frame as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the 15mer OLPs Spanning Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the 15mer OLPs spanning Open Reading Frame 3a as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 1st of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 1st of 4 OLP pools as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 2nd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 2nd of 4 OLP pools as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 3rd of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 3rd of 4 OLP pools as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the Consensus Spike (Wuhan-1) Whole Protein, 4th of 4 OLP Pools for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Consensus Spike (Wuhan-1) whole protein, 4th of 4 OLP pools as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the S1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the S1 as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the S2 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the S2 as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the Spike for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the Spike as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean Spot Forming Units Per Million of the 15mer OLP (Overlapping Peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Mean spot forming units per million of the 15mer OLP (overlapping peptides) Spanning Membrane, Nucleocapsid, and Open Reading Frame 3a as measured by ELISpot.
Measured: Day 1 Pre-Vaccination 1, Day 15 Post Vaccination 1, Day 29 Post vaccination 1, Day 85 Post Vaccination 1, Day 181 Post Vaccination 1
Mean T-cells Expressing IL-2 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-4 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-10 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-13 in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing TNF-alpha in pg/mL for Groups 1 and 3A at Day 29 Post Vaccination 1
Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 29 Post Vaccination 1
Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-2 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay
Measured: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-4 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay
Measured: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-10 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay
Measured: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-13 in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay
Measured: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing TNF-alpha in pg/mL for Groups 3B and 4 at Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay
Measured: Day 113 Post Vaccination 1 (29 Days Post Vaccination 2)
Mean T-cells Expressing IL-2 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-2 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-4 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-4 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-10 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-10 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing IL-13 in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing IL-13 in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Mean T-cells Expressing TNF-alpha in pg/mL for Groups 5 and 6 at Day 29 Post Vaccination 1
Mean T-cells Expressing TNF-alpha in pg/mL as measured by MSD cytokine assay
Measured: Day 29 Post Vaccination 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start25 Mar 2021
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Gritstone bio, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776317
- Sponsor's protocol ID
- 20-0034
- Other IDs
- 5UM1AI148684-02
- Status last verified
- 20 Apr 2022
- First submitted
- 25 Feb 2021
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Whitaker JA, Rebolledo PA, Abate G, Babu TM, Rouphael NG, Wald A, El Sahly HM, Jooss K, Hart MG, Makowski M, Mu J, Carmack A, Archer JI, Roberts PC, Makhene M, Posavad CM, McElrath MJ, De Rosa SC, Coler R, Montefiori D, Eaton A, Suthar MS, Atmar RL, Hoft DF; DMID 20-0034 Study Team. The safety, reactogenicity, and immunogenicity of the self-amplifying mRNA COVID-19 vaccine GRT-R910 as a booster in healthy adults. Vaccine. 2026 Apr 2;77:128358. doi: 10.1016/j.vaccine.2026.128358. Epub 2026 Feb 25.
PubMed 41740461
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial to Evaluate the Safety, Immunogenicity, and Reactogenicity of Heterologous and Homologous Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic Vaccines Against SARS-CoV-2 in Healthy Adults
- ClinicalTrials.gov ID
- NCT04776317
- Acronym / sponsor ID
- 20-0034
- Conditions
- COVID-19
- Keywords
- Immunogenicity, Prime-Boost, Reactogenicity, Safety, SARS-CoV-2, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Gritstone bio, Inc.
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized study of the safety, tolerability, and immunogenicity of investigational ChAd and SAM SARS-CoV-2 vaccines in healthy adult subjects. Homologous and heterologous prime-boost vaccination schedules (Stage 1), as well as boost(s) after receipt of COVID-19 EUA/licensed vaccines (Stage 2) will be examined. Subjects' willingness to receive ChAd vaccines will be assessed and documented at the time of informed consent and considered to determine group assignments. This phase 1 study will enroll 17 Stage 1 and up to 118 Stage 2 subjects. Eligible subjects will be enrolled in different groups based on their age (18-60 years old and >60 years old) and their EUA/licensed COVID-19 vaccination status. A sentinel approach with 72-hour (Stage 1, and Stage 2, Groups 5, 6, 8-10, 12, 13-15) or 7-day observation times (Groups 7 and 11) will be used, before recruiting the remainder of each dose escalation group. Decisions about dose escalation will be determined by the SSC with consultation with the DSMB as needed after all subjects in each group have been observed through Day 8 post first study vaccination. All subjects will be followed through 12 months after their last study vaccination. Vaccinated subjects will be carefully monitored for exposure and infection to SARS-CoV-2 throughout the study. Escalation to the highest dose (10 µg) of SAM-S-TCE in younger subjects will proceed only following safety assessments of the 10 µg dose in older subjects for a period of 28 days post-vaccination. In addition, the dosage of SAM-S-TCE given as a double boost to subjects previously vaccinated with the Johnson \& Johnson/Janssen Ad26 COVID-19 EUA/licensed vaccine in Groups 8A, 8B, and 12A, 12B will be determined based on the dose escalation reactogenicity and immunogenicity results in Groups 5-7 and 9-11, respectively. After protocol version 9.0 was implemented, it was decided not to enroll subjects into Groups 7 and 8 because of competing priorities and predicted difficulties enrolling into these two groups.
The primary objectives of this study are 1) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as prime-boost in healthy naïve adult subjects, 2) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as first or second boost in healthy adult subjects previously vaccinated with an mRNA or adenoviral-vectored COVID-19 EUA/licensed vaccine.
Detailed description
This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized study of the safety, tolerability, and immunogenicity of investigational ChAd and SAM SARS-CoV-2 vaccines in healthy adult subjects. Homologous and heterologous prime-boost vaccination schedules (Stage 1), as well as boost(s) after receipt of COVID-19 EUA/licensed vaccines (Stage 2) will be examined. Subjects' willingness to receive ChAd vaccines will be assessed and documented at the time of informed consent and considered to determine group assignments. This phase 1 study will enroll 17 Stage 1 and up to 118 Stage 2 subjects. Eligible subjects will be enrolled in different groups based on their age (18-60 years old and >60 years old) and their EUA/licensed COVID-19 vaccination status. A sentinel approach with 72-hour (Stage 1, and Stage 2, Groups 5, 6, 8-10, 12, 13-15) or 7-day observation times (Groups 7 and 11) will be used, before recruiting the remainder of each dose escalation group. Decisions about dose escalation will be determined by the SSC with consultation with the DSMB as needed after all subjects in each group have been observed through Day 8 post first study vaccination. All subjects will be followed through 12 months after their last study vaccination. Vaccinated subjects will be carefully monitored for exposure and infection to SARS-CoV-2 throughout the study. Escalation to the highest dose (10 µg) of SAM-S-TCE in younger subjects will proceed only following safety assessments of the 10 µg dose in older subjects for a period of 28 days post-vaccination. In addition, the dosage of SAM-S-TCE given as a double boost to subjects previously vaccinated with the Johnson \& Johnson/Janssen Ad26 COVID-19 EUA/licensed vaccine in Groups 8A, 8B, and 12A, 12B will be determined based on the dose escalation reactogenicity and immunogenicity results in Groups 5-7 and 9-11, respectively. After protocol version 9.0 was implemented, it was decided not to enroll subjects into Groups 7 and 8 because of competing priorities and predicted difficulties enrolling into these two groups.
The primary objectives of this study are 1) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as prime-boost in healthy naïve adult subjects, 2) To assess the safety and tolerability of different doses of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE when administered as first or second boost in healthy adult subjects previously vaccinated with an mRNA or adenoviral-vectored COVID-19 EUA/licensed vaccine. The secondary objective of this study is to assess the humoral immunogenicity of ChAd-S or ChAd-S-TCE, and SAM-S or SAM-S-TCE.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Stage 1 (Naïve) Group 1 | Experimental | Biological: ChAdV68-S, Biological: SAM-LNP-S, Other: Sodium Chloride, 0.9%5 x 10^10 viral particles of ChAdV68-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 29 in participants from 18 to 60 years of age. N=4 |
| Stage 1 (Naïve) Group 3A | Experimental | Biological: SAM-LNP-S, Other: Sodium Chloride, 0.9%30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 29 in participants from 18 to 60 years of age. N=3 |
| Stage 1 (Naïve) Group 3B | Experimental | Biological: SAM-LNP-S, Other: Sodium Chloride, 0.9%30 mcg SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 3 mcg of SAM-LNP-S administered through 0.25 mL intramuscular injection in the deltoid muscle on or after Day 85 and no later than Day 130 in participants from 18 to 60 years of age. N=7 |
| Stage 1 (Naïve) Group 4 | Experimental | Biological: SAM-LNP-S-TCE, Other: Sodium Chloride, 0.9%10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on or after Day 85 and no later than Day 130 in participants from 18 to 60 years of age. N=3 |
| Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 13 | Experimental | Biological: ChAdV68-S-TCE, Other: Sodium Chloride, 0.9%5 x 10^10 viral particles of ChAdV68-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and on or after Day 113 in participants older than 60 years of age. N=7-10 |
| Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 14 | Experimental | Biological: ChAdV68-S-TCE, Other: Sodium Chloride, 0.9%1 x 10^11 viral particles of ChAdV68-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=7-10 |
| Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 15 | Experimental | Biological: ChAdV68-S-TCE, Other: Sodium Chloride, 0.9%5 x 10^11 viral particles of ChAdV68-S-TCE administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=7-10 |
| Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 10A,B | Experimental | Biological: SAM-LNP-S-TCE6 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8-12 |
| Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 11A,B | Experimental | Biological: SAM-LNP-S-TCE10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8-12 |
| Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 12A,B | Experimental | Biological: SAM-LNP-S-TCE10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 10 mcg SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 57 in participants older than 60 years of age. N=8-12 |
| Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 9 | Experimental | Biological: SAM-LNP-S-TCE, Other: Sodium Chloride, 0.9%3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8 |
| Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 5 | Experimental | Biological: SAM-LNP-S-TCE, Other: Sodium Chloride, 0.9%3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=10 |
| Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 6 | Experimental | Biological: SAM-LNP-S-TCE, Other: Sodium Chloride, 0.9%6 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=10 |
| Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 7A,B | Experimental | Biological: SAM-LNP-S-TCE10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=8-12 |
| Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 8A,B | Experimental | Biological: SAM-LNP-S-TCE10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 57 in participants from 18 to 60 years of age. N=8-12 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Subjects eligible to participate in this trial must meet all of the following inclusion criteria:
- Provide written informed consent prior to initiation of any study procedures
- Able and willing (in the investigator's opinion) to comply with all study requirements
- Are men or non-pregnant women aged 18 years or older at enrollment
- Are in good health*
Key exclusion criteria (39 listed)
- Subjects eligible to participate in this trial must not meet any of the following exclusion criteria:
- History of prior confirmed (PCR or antigen test positive) COVID-19 less than 112 days prior to enrollment.
- Positive for anti-nucleoprotein SARS-CoV-2 specific antibody by enzyme-linked immunosorbent assay (ELISA) and had the history of upper respiratory illness (URI) compatible with COVID-19 during the 112 days prior to enrollment (seropositivity without a history of URI during the 112 days prior to enrollment will be considered remotely infected persons eligible for enrollment).
- Positive nasal swab polymerase chain reaction (PCR) at screening.
- Body mass index (BMI) > 30 kg/m^2 for Stage 1 participants and BMI > 35 kg/m^2 for Stage 2 participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChAdV68-SChimpanzee Adenovirus serotype 68 - Spike (ChAdV68-S) is a replication-defective, E1, E3 E4Orf2-4 deleted adenoviral vector based on chimpanzee adenovirus 68 (C68, 68/SAdV-25, originally designated as Pan 9), which belongs to the sub-group E adenovirus family. A single 0.5 mL intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms. | Biological | Stage 1 (Naïve) Group 1 |
| ChAdV68-S-TCEChimpanzee Adenovirus 68 - Spike plus additional SARS-CoV-2 T cell epitopes (ChAdV68-S-TCE) is a replication-defective, E1, E3 E4Orf2-4 deleted adenoviral vector based on chimpanzee adenovirus 68 (C68, 68/SAdV-25, originally designated as Pan 9), which belongs to the sub-group E adenovirus family. A single 0.5- or 1.0-mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms. | Biological | Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 13, Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 14, Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 15 |
| SAM-LNP-SSelf-Amplifying mRNA - Lipid Nanoparticles - Spike (SAM-LNP-S) is a SAM vector based on Venezuelan Equine Encephalitis Virus (VEEV). A single 0.25 mL or 0.5 mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms. | Biological | Stage 1 (Naïve) Group 1, Stage 1 (Naïve) Group 3A, Stage 1 (Naïve) Group 3B |
| SAM-LNP-S-TCESelf-Amplifying mRNA - Lipid Nanoparticles -Spike plus additional SARS-CoV-2 T cell epitopes (SAM-S-TCE) is a SAM vector based on Venezuelan Equine Encephalitis Virus (VEEV). A single 0.25 or 0.5 mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms. | Biological | Stage 1 (Naïve) Group 4, Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 5, Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 6, Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 7A,B, Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 8A,B, Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 10A,B, Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 11A,B, Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 12A,B, Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 9 |
| Sodium Chloride, 0.9%The diluent used for this study will be 0.9% Sodium Chloride Injection, USP, and is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each milliliter (mL) contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. | Other | Stage 1 (Naïve) Group 1, Stage 1 (Naïve) Group 3A, Stage 1 (Naïve) Group 3B, Stage 1 (Naïve) Group 4, Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 13, Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 14, Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 15, Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 5, Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 6, Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 9 |
Primary outcome
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Time frame: Day 1 to study completion through up to 1 year post last dose
Number of participants that experienced any NOCMCs during the course of the study
Frequency of Any Potentially Immune-mediated Medical Conditions (PIMMCs)
Time frame: Day 1 to study completion through up to 1 year post last dose
Number of participants that experienced any PIMMCs during the course of the study
Frequency of Any Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 to study completion through up to 1 year post last dose
Number of participants that experienced any MAAEs during the course of the study
Frequency of Any Laboratory AE
Time frame: Through 7 days post each study vaccination
Number of participants that experienced any laboratory AE
Frequency of Any Serious Adverse Events (SAEs)
Time frame: Day 1 to study completion through up to 1 year post last dose
The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)
Time frame: Day 1 through Day 8 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and through 7 days post any vaccination for Groups 1, 3A, 3b and 4.
Number of participants who experienced any systemic solicited AEs through 7 days post any vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever.
Frequency of Local Solicited Reactogenicity Adverse Events (AEs)
Time frame: Day 1 through Day 8 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and through 7 days post any vaccination for Groups 1, 3A, 3b and 4.
Number of participants who experienced any local solicited AEs through 7 days post any vaccination. Local events include: pain at injection site, erythema, and induration.
Frequency of Any Unsolicited Adverse Events (AEs)
Time frame: Day 1 through Day 29 for Groups 5, 6, 9, 10, 11, 13, 14 and 15 and 28 days post any vaccination for Groups 1, 3A, 3b and 4.
Number of participants who experienced any unsolicited AEs through 28 days post vaccination
130 secondary outcomes
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A
Time frame: Day 57 Post Vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A
Time frame: Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4
Time frame: Day 169 Post Vac 1 (85 Days Post Vac 2), Day 265 Post Vac 1 (181 Days Post Vac 2), Day 450 Post Vac 1 (366 Days Post Vac 2)
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean Fold Rise of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 1 and 3A
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 1 and 3A
Time frame: Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 1 and 3A
Time frame: Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 3B and 4
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 3B and 4
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 3B and 4
Time frame: Day 169 Post Vaccination 1 (85 Days Post Vaccination 2), Day 265 Post Vaccination 1 (181 Days Post Vaccination 2), Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean of Pseudovirus Neutralization ID50 Against D614G for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.1 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean of Pseudovirus Neutralization ID50 Against BA.4/5 for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 1 and 3A
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Titer of RBD IgG as Measured by ELISA for Groups 3B and 4
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean in Titer of RBD IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 1 and 3A
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Geometric Mean Titer of S-2P IgG as Measured by ELISA for Groups 3B and 4
Time frame: Day 1 Pre-Vaccination 1, Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Geometric Mean in Titer of S-2P IgG as Measured by ELISA for Groups 5, 6, 9, 10, 11, 13, 14, and 15
Time frame: Day 1 Pre-Vaccination, Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 1 and 3A
Time frame: Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 1 and 3A
Time frame: Day 57 Post vaccination 1 (29 Days Post Vaccination 2), Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 1 and 3A
Time frame: Day 209 Post Vaccination 1 (181 Days Post Vaccination 2), Day 394 Post Vaccination 1 (366 Days Post Vaccination 2)
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 3B and 4
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 3B and 4
Time frame: Day 29 Post Vaccination 1, Day 57 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post Vaccination 1, Day 113 Post Vaccination 1, Day 169 Post Vaccination 1, Day 265 Post Vaccination 1, Day 450 Post Vaccination 1
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 3B and 4
Time frame: Day 169 Post Vaccination 1 (85 Days Post Vaccination 2), Day 265 Post Vaccination 1 (181 Days Post Vaccination 2), Day 450 Post Vaccination 1 (366 Days Post Vaccination 2)
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against D614G S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.1 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Percent of Participants Who Seroconverted Based on Pseudovirus Neutralization ID50 Against BA.4/5 S-2P for Groups 5, 6, 9, 10, 11, 13, 14 and 15
Time frame: Day 15 Post Vaccination, Day 29 Post Vaccination, Day 85 Post Vaccination, Day 181 Post Vaccination, Day 366 Post Vaccination
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 1 and 3A
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 1 and 3A
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 57 Post vaccination 1 (29 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any COV2 S Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With Any TCE Stimulation Expressing IL-4 or IL-5 or IL-13 and CD154 for Groups 3B and 4
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Mean Percent of CD4+ T Cells With G-Mem Stimulation Expressing IFNg and/or IL-2 for Groups 3B and 4
Time frame: Day 1 Pre-Vaccination, Day 29 Post Vaccination 1, Day 85 Post Vaccination 1, Day 99 Post vaccination 1 (15 Days Post Vaccination 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41740461Whitaker JA, Rebolledo PA, Abate G, Babu TM, Rouphael NG, Wald A, El Sahly HM, Jooss K, Hart MG, Makowski M, Mu J, Carmack A, Archer JI, Roberts PC, Makhene M, Posavad CM, McElrath MJ, De Rosa SC, Coler R, Montefiori D, Eaton A, Suthar MS, Atmar RL, Hoft DF; DMID 20-0034 Study Team. The safety, reactogenicity, and immunogenicity of the self-amplifying mRNA COVID-19 vaccine GRT-R910 as a booster in healthy adults. Vaccine. 2026 Apr 2;77:128358. doi: 10.1016/j.vaccine.2026.128358. Epub 2026 Feb 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ChAdV68-S, ChAdV68-S-TCE and SAM-LNP-S in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs) (time frame: Day 1 to study completion through up to 1 year post last dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04776317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.