Covid19Phase 1/2NCT04845191
COVID-19 Subcutaneously and Orally Administered Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines
A Phase 1/2 study testing hAd5-S-Fusion+N-ETSD vaccine in people with Covid19, run by ImmunityBio, Inc..
Trial summary
This is a phase 1/2 study in adult healthy subjects that have previously been vaccinated with an FDA-authorized vaccine against COVID-19. This clinical trial is designed to assess the safety, efficacy, reactogenicity, and immunogenicity of hAd5-S-Fusion+N-ETSD formulated for subcutaneous and oral (capsule)… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- hAd5-S-Fusion+N-ETSD vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to 14 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults, age ≥ 18 years, inclusive, at time of enrollment, that have previously received an FDA-authorized COVID-19 vaccine (both prime and boost) ≥14 days and
- ≤ 6 months before enrollment.
- Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Agrees to the collection of biospecimens (eg, NP swabs and/or saliva sample) and venous blood per protocol.
- Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- Ability to swallow a capsule.
- Temperature < 38°C.
- Agreement to practice effective contraception for female subjects of childbearing potential and non-sterile males. Female subjects of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male subjects must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, IUDs, oral contraceptives, and abstinence.
Who cannot join
- Persistent grade ≥ 2 AEs related to previous COVID-19 vaccination at the time of enrollment.
- Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
- Pregnant and nursing women. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female subject of childbearing potential.
- Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.
- Pulmonary fibrosis.
- Bone marrow or organ transplantation.
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- Extreme obesity (defined as BMI of 35 kg/m2 or higher).
- Diabetes.
- Chronic kidney disease.
- Liver disease.
- Sickle cell disease.
- Thalassemia.
- Any disease associated with acute fever, or any infection.
- Self-reported history of SARS.
- History of hepatitis B or hepatitis C.
- HIV or other acquired or hereditary immunodeficiency.
- Serious cardiovascular diseases, such as heart failure, coronary artery disease, cardiomyopathies, arrhythmia, conduction block, myocardial infarction, pulmonary hypertension, severe hypertension without controllable drugs, etc.
- Cerebrovascular disease.
- Cystic fibrosis.
- Neurologic conditions, such as dementia.
- Hereditary or acquired angioneurotic edema.
- No spleen or functional asplenia.
- Platelet disorder or other bleeding disorder that may cause injection contraindication.
- Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness within 3 months before administration of study vaccine. (Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.)
- Prior administration of blood products in last 4 months.
- Currently receiving treatment for cancer or history of cancer in the last five years (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- According to the judgement of investigator, various medical, psychological, social or other conditions that could affect the subjects ability to sign informed consent.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
About this study
Official title: Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Subcutaneously- and Orally- Administered Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use
This is a phase 1/2 study in adult healthy subjects that have previously been vaccinated with an FDA-authorized vaccine against COVID-19. This clinical trial is designed to assess the safety, efficacy, reactogenicity, and immunogenicity of hAd5-S-Fusion+N-ETSD formulated for subcutaneous and oral (capsule) administration.
- Conditions
- Covid19
- Being tested
- hAd5-S-Fusion+N-ETSD 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.
hAd5-S-Fusion+N-ETSD vaccineBiological
hAd5-S-Fusion+N-ETSD is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen S fusion protein and N with an enhanced T-cell stimulation domain.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort 1: hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous | Experimental | Cohort 1 (n=20): hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous on Day 1 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine |
| Experimental: Cohort 2: hAd5-S-Fusion+N-ETSD Subcutaneous and Oral | Experimental | Cohort 2 (n=20): hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous and 1 × 10e10 IU/dose Oral on Day 1 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Safety: Incidence of MAAEs and SAEs
Incidence of MAAEs and SAEs through 1 week post final vaccine administration
Measured: through 1 week post final vaccine administration
Phase 1 Safety: Incidence and severity of solicited local reactogenicity AEs
Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration
Measured: through 1 week post final vaccine administration
Phase 1 Safety: Incidence and severity of solicited systemic reactogenicity AEs
Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Measured: through 1 week post final vaccine administration
Phase 1 Safety: Incidence and severity of unsolicited AEs
Incidence and severity of unsolicited AEs through 1 week post final vaccine administration
Measured: through 1 week post final vaccine administration
Phase 1 Safety: Incidence of MAAEs and SAEs
Incidence of MAAEs and SAEs through 30 days
Measured: through 30 days
Phase 1 Safety: Incidence of MAAEs and SAEs
Incidence of MAAEs and SAEs at 6 months post final vaccine administration
Measured: 6 months post final vaccine administration
Phase 1 Safety: Incidence and severity of unsolicited AEs
Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
Measured: through 30 days post final vaccine administration
Phase 1 Safety: Incidence of changes of laboratory safety examinations
Incidence of abnormal changes of laboratory safety examinations
Measured: Day 365
Phase 1 Safety: Vital Sign - Temperature
Changes in vital signs from Grades 1-4:
measured in (°C) or (°F)
Measured: Day 365
Phase 1 Safety: Vital Sign - Heart Rate
Changes in vital signs from Grades 1-4:
measured by how many heart beats per minute
Measured: Day 365
Phase 1 Safety: Vital Sign - Blood Pressure
Changes in vital signs from Grades 1-4:
systolic/diastolic - measured in mm Hg
Measured: Day 365
Phase 1 Safety: Vital Sign - Respiratory Rate
Changes in vital signs from Grades 1-4:
measured in how many breaths per minute
Measured: Day 365
Phase 2 Efficacy: Percent of subjects that show an increase in N-reactive T cells
Percent of subjects that show an increase in N-reactive T cells as assayed by N-Tiferon assay (≥ 25 pg/mL increase in cytokine concentration from baseline)
Measured: from baseline to Day 365
Secondary outcomes (21)
Phase 1 Humoral Immunogenicity: GMT of S-specific and N-specific antibodies
GMT of S-specific and N-specific antibodies against 2019 novel coronavirus
Measured: Day 365
Phase 1 Humoral Immunogenicity: GMT of neutralizing antibody
GMT of neutralizing antibody
Measured: Day 365
Phase 1 Mucosal Immunogenicity: GMT of IgA antibody levels
GMT of IgA antibody levels
Measured: Day 365
Phase 1 Cellular Immunogenicity: T cell activity
T cell activity against SARS-CoV-2 S protein and N protein. T cell activity against SARS-CoV-2 S protein and N protein. ImmunityBio has developed a rapid assay (N-Tiferon) to detect SARS-CoV-2-specific T cell responses directly in whole blood from participants in QUILT-4.001 vaccinated with hAd5 S-Fusion+N-ETSD targeting the S and N antigens of SARS-CoV-2. This assay detected interferon-γ (IFN-γ)-secreting S- and N-specific T cells directly in whole blood post-vaccination.
Measured: Day 365
Phase 2 Efficacy: Incidence and severity of COVID-19 ≥14 days after vaccination
Incidence and severity of COVID-19 ≥14 days after vaccination in subjects with no evidence of past SARS-CoV-2 infection. It applies to ≥3 for injection site reaction, fever, and other AEs. It also includes signs and symptoms of hypersensitivity which may include red rash (excluding site of injection), swollen throat or swollen areas of the body, wheezing, fainting, chest tightness, difficulty breathing, hoarse voice, difficulty swallowing, vomiting, diarrhea, and stomach cramping.
Measured: ≥14 days after vaccination
Phase 2 Efficacy: Mean SARS-CoV-2 viral load
Mean SARS-CoV-2 viral load for subjects with confirmed COVID-19 ≥14 days after vaccination
Measured: Day 365
Phase 2 Efficacy: Humoral Immunogenicity - GMT of S-specific and N-specific antibodies
GMT of S-specific and N-specific antibodies against 2019 novel coronavirus
Measured: Day 365
Phase 2 Efficacy: Humoral Immunogenicity - GMT of neutralizing antibody
GMT of neutralizing antibody
Measured: Day 365
Phase 2 Efficacy: Mucosal Immunogenicity - GMT of IgA antibody levels
GMT of IgA antibody levels
Measured: Day 365
Phase 2 Efficacy: Cellular Immunogenicity - T cell activity
T cell activity against SARS-CoV-2 S protein and N protein measured
Measured: Day 365
Phase 2 Safety: Incidence of MAAEs and SAEs
Incidence of MAAEs and SAEs through 1 week post final vaccine administration
Measured: through 1 week post final vaccine administration
Phase 2 Safety: Incidence and severity of solicited local reactogenicity AEs
Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration
Measured: through 1 week post final vaccine administration
Phase 2 Safety: Incidence and severity of solicited systemic reactogenicity AEs
Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Measured: through 1 week post final vaccine administration
Phase 2 Safety: Incidence and severity of unsolicited AEs
Incidence and severity of unsolicited AEs through 1 week post final vaccine administration
Measured: through 1 week post final vaccine administration
Phase 2 Safety: Incidence of MAAEs and SAEs
Incidence of MAAEs and SAEs through 30 days and 6 months post final vaccine administration
Measured: through 30 days and 6 months post final vaccine administration
Phase 2 Safety: Incidence and severity of unsolicited AEs
Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
Measured: through 30 days post final vaccine administration
Phase 2 Safety: Incidence of changes of laboratory safety examinations
Incidence of abnormal changes of laboratory safety examinations
Measured: Day 365
Phase 2 Safety: Vital Sign - Temperature
Changes in vital signs from Grades 1-4:
measured in (°C) or (°F)
Measured: Day 365
Phase 2 Safety: Vital Sign - Heart rate
Changes in vital signs from Grades 1-4:
measured by how many heart beats per minute
Measured: Day 365
Phase 2 Safety: Vital Sign - Blood Pressure
Changes in vital signs from Grades 1-4:
systolic/diastolic - measured in mm Hg
Measured: Day 365
Phase 2 Safety: Vital Sign - Respiratory rate
Changes in vital signs from Grades 1-4:
measured in how many breaths per minute
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completion14 Dec 2021
Why it stopped: The sponsor has changed the development plans which is not for safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Open label 2 Cohort Phase 1 Study leading to Randomized Phase 2 Study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845191
- Sponsor's protocol ID
- COVID-4.009
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Subcutaneously- and Orally- Administered Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use
- ClinicalTrials.gov ID
- NCT04845191
- Acronym / sponsor ID
- COVID-4.009
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor has changed the development plans which is not for safety reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
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 phase 1/2 study in adult healthy subjects that have previously been vaccinated with an FDA-authorized vaccine against COVID-19. This clinical trial is designed to assess the safety, efficacy, reactogenicity, and immunogenicity of hAd5-S-Fusion+N-ETSD formulated for subcutaneous and oral (capsule) administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Open label 2 Cohort Phase 1 Study leading to Randomized Phase 2 Study
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort 1: hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous | Experimental | Biological: hAd5-S-Fusion+N-ETSD vaccineCohort 1 (n=20): hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous on Day 1 |
| Experimental: Cohort 2: hAd5-S-Fusion+N-ETSD Subcutaneous and Oral | Experimental | Biological: hAd5-S-Fusion+N-ETSD vaccineCohort 2 (n=20): hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous and 1 × 10e10 IU/dose Oral on Day 1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adults, age ≥ 18 years, inclusive, at time of enrollment, that have previously received an FDA-authorized COVID-19 vaccine (both prime and boost) ≥14 days and
- ≤ 6 months before enrollment.
- Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Agrees to the collection of biospecimens (eg, NP swabs and/or saliva sample) and venous blood per protocol.
- Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Key exclusion criteria (28 listed)
- Persistent grade ≥ 2 AEs related to previous COVID-19 vaccination at the time of enrollment.
- Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
- Pregnant and nursing women. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female subject of childbearing potential.
- Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.
- Pulmonary fibrosis.
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 |
|---|---|---|
| hAd5-S-Fusion+N-ETSD vaccinehAd5-S-Fusion+N-ETSD is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen S fusion protein and N with an enhanced T-cell stimulation domain. | Biological | Experimental: Cohort 1: hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous, Experimental: Cohort 2: hAd5-S-Fusion+N-ETSD Subcutaneous and Oral |
Primary outcome
Phase 1 Safety: Incidence of MAAEs and SAEs
Time frame: through 1 week post final vaccine administration
Incidence of MAAEs and SAEs through 1 week post final vaccine administration
Phase 1 Safety: Incidence and severity of solicited local reactogenicity AEs
Time frame: through 1 week post final vaccine administration
Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration
Phase 1 Safety: Incidence and severity of solicited systemic reactogenicity AEs
Time frame: through 1 week post final vaccine administration
Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Phase 1 Safety: Incidence and severity of unsolicited AEs
Time frame: through 1 week post final vaccine administration
Incidence and severity of unsolicited AEs through 1 week post final vaccine administration
Phase 1 Safety: Incidence of MAAEs and SAEs
Time frame: through 30 days
Incidence of MAAEs and SAEs through 30 days
Phase 1 Safety: Incidence of MAAEs and SAEs
Time frame: 6 months post final vaccine administration
Incidence of MAAEs and SAEs at 6 months post final vaccine administration
Phase 1 Safety: Incidence and severity of unsolicited AEs
Time frame: through 30 days post final vaccine administration
Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
Phase 1 Safety: Incidence of changes of laboratory safety examinations
Time frame: Day 365
Incidence of abnormal changes of laboratory safety examinations
Phase 1 Safety: Vital Sign - Temperature
Time frame: Day 365
Changes in vital signs from Grades 1-4: measured in (°C) or (°F)
Phase 1 Safety: Vital Sign - Heart Rate
Time frame: Day 365
Changes in vital signs from Grades 1-4: measured by how many heart beats per minute
Phase 1 Safety: Vital Sign - Blood Pressure
Time frame: Day 365
Changes in vital signs from Grades 1-4: systolic/diastolic - measured in mm Hg
Phase 1 Safety: Vital Sign - Respiratory Rate
Time frame: Day 365
Changes in vital signs from Grades 1-4: measured in how many breaths per minute
Phase 2 Efficacy: Percent of subjects that show an increase in N-reactive T cells
Time frame: from baseline to Day 365
Percent of subjects that show an increase in N-reactive T cells as assayed by N-Tiferon assay (≥ 25 pg/mL increase in cytokine concentration from baseline)
21 secondary outcomes
Phase 1 Humoral Immunogenicity: GMT of S-specific and N-specific antibodies
Time frame: Day 365
Phase 1 Humoral Immunogenicity: GMT of neutralizing antibody
Time frame: Day 365
Phase 1 Mucosal Immunogenicity: GMT of IgA antibody levels
Time frame: Day 365
Phase 1 Cellular Immunogenicity: T cell activity
Time frame: Day 365
Phase 2 Efficacy: Incidence and severity of COVID-19 ≥14 days after vaccination
Time frame: ≥14 days after vaccination
Phase 2 Efficacy: Mean SARS-CoV-2 viral load
Time frame: Day 365
Phase 2 Efficacy: Humoral Immunogenicity - GMT of S-specific and N-specific antibodies
Time frame: Day 365
Phase 2 Efficacy: Humoral Immunogenicity - GMT of neutralizing antibody
Time frame: Day 365
Phase 2 Efficacy: Mucosal Immunogenicity - GMT of IgA antibody levels
Time frame: Day 365
Phase 2 Efficacy: Cellular Immunogenicity - T cell activity
Time frame: Day 365
Phase 2 Safety: Incidence of MAAEs and SAEs
Time frame: through 1 week post final vaccine administration
Phase 2 Safety: Incidence and severity of solicited local reactogenicity AEs
Time frame: through 1 week post final vaccine administration
Phase 2 Safety: Incidence and severity of solicited systemic reactogenicity AEs
Time frame: through 1 week post final vaccine administration
Phase 2 Safety: Incidence and severity of unsolicited AEs
Time frame: through 1 week post final vaccine administration
Phase 2 Safety: Incidence of MAAEs and SAEs
Time frame: through 30 days and 6 months post final vaccine administration
Phase 2 Safety: Incidence and severity of unsolicited AEs
Time frame: through 30 days post final vaccine administration
Phase 2 Safety: Incidence of changes of laboratory safety examinations
Time frame: Day 365
Phase 2 Safety: Vital Sign - Temperature
Time frame: Day 365
Phase 2 Safety: Vital Sign - Heart rate
Time frame: Day 365
Phase 2 Safety: Vital Sign - Blood Pressure
Time frame: Day 365
Phase 2 Safety: Vital Sign - Respiratory rate
Time frame: Day 365
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hAd5-S-Fusion+N-ETSD vaccine in people with Covid19, run by ImmunityBio, Inc..
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 8 inclusion and 28 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: withdrawn, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Phase 1 Safety: Incidence of MAAEs and SAEs (time frame: through 1 week post final vaccine administration). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2025.