Covid19Phase 1CVXGA1-001NCT04954287
Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and Adolescents
A Phase 1 study testing CVXGA1 low dose and CVXGA1 high dose in people with Covid19, run by CyanVac LLC at 4 sites in United States.
Trial summary
This Phase 1 trial is an open-label trial to evaluate the safety, reactogenicity and immunogenicity of two dosages (10^6 PFU and 10^7 PFU) of intranasal CVXGA1 administered as a single dose in healthy adults age 18-55 years and in adolescents age 12-17. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- CVXGA1 low dose and CVXGA1 high dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Aug 2021to 10 Jun 2023
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide informed consent and assent as applicable prior to initiation of any trial procedures.
- Be able to understand and agrees to comply with planned trial procedures and be available for all trial visits.
- Agrees to the collection of venous blood per protocol.
- Healthy male or non-pregnant female between 12 and 55 years of age inclusive at time of enrollment who are not at high risk of SARS-CoV-2 exposure defined as individuals whose health status, profession, locations or circumstances put them at high risk of exposure to SARS-CoV-2 and COVID-19.
- Body Mass Index (BMI) <40.0 kg/m2 (or < 35.0 kg/m2 if obesity-related health conditions are present) at screening. Subjects must weigh a minimum of 31 kg.
- Women of childbearing potential* must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception.*, **** Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the criteria do not apply to subjects in a same sex relationship).
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- Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to vaccination.
- Male subjects of childbearing potential*: use of condoms to ensure effective contraception with a female partner of childbearing potential from vaccination until 90 days after vaccination. If barrier methods are to be used, then double barrier methods of protection are required i.e. male condom with a cap, diaphragm or sponge with spermicide. *Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy.
- Male subjects agree to refrain from sperm donation from the time of vaccination until 90 days after vaccination.
- Female subjects agree to refrain from egg donation from time of vaccination until 90 days after vaccination.
- In good health.*
- Oral temperature of 97.0°F (36.1°C) to less than 100.4° Fahrenheit (37.8° C).
- Pulse is less than 100 beats per minute.
- Systolic blood pressure (BP) is 85 to 150 mmHg, inclusive.
- Diastolic blood pressure <95 mmHg, inclusive. Repeat blood pressure measurements are permitted.
- Clinical screening laboratory evaluations (white blood cells (WBC) [total and differential counts], hemoglobin, platelets, alanine transaminase, aspartate transaminase, creatinine, alkaline phosphatase, total bilirubin, lipase, prothrombin time and partial thromboplastin time) are within acceptable normal reference ranges at the clinical laboratory being used. Alternatively, the clinical laboratory abnormalities grading scale noted in the FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers enrolled in Preventive Vaccine Clinical Trials may be used.
- Must agree to have samples stored for secondary research.
- Agrees to adhere to pandemic public health guidance on preventing SARS-CoV-2 infection (e.g. wearing a mask, keeping physically distant, sheltering-in) throughout trial duration.
- Must agree to refrain from donating blood or plasma during the trial (outside of this trial).
- Seronegative to SARS-CoV-2 for subjects in Group 1, 2, and negative for SARS-CoV-2 by PCR at screening for all Groups.
- For Groups 3 and 4 only, documented receipt of at least two-doses of COVID mRNA vaccine (any combination of Pfizer Comirnaty® and Moderna Spikevax™ vaccines) with the last dose at least 5 months prior to planned dosing of CVXGA1, and without receipt of any other COVID vaccines. In addition, subjects may not have had known COVID-19 infection in the 5 months prior to planned dosing of CVXGA1 study vaccine.
Who cannot join
- Positive pregnancy test either at screening or just prior to vaccine administration.
- Female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination.
- Anyone at high risk of severe COVID-19 disease as per current CDC guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>) or has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes trial participation.* *Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
- Presence of self-reported or medically documented significant medical or psychiatric condition(s).*
- Has an acute illness*, as determined by the participating site PI or appropriate sub- investigator, with or without fever [oral temperature ≥ 38.0° Celsius (100.4° Fahrenheit)] within 72 hours of vaccination. *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
- Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
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- Has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration.
- Currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period.
- Has previously participated in an investigational trial of prophylaxis or treatment for SARS-CoV-2 infection or COVID-19 disease, except for Groups 3 and 4, who may have previously participated in investigational trials in which the subject received only the Pfizer Comirnaty® and/or Moderna Spikevax™ vaccines.
- Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
- Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.*
- Anticipating the need for immunosuppressive treatment within the next 6 months.
- Received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial.
- Has any blood dyscrasias or significant disorder of coagulation.
- Has any chronic liver disease, including fatty liver.
- Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration.
- Received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination.
- Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination.
- Prior receipt of a COVID-19 vaccine (except for prior doses of the Pfizer Comirnaty® and/or Moderna Spikevax™ vaccines in subjects enrolled in Groups 3 and 4), or planned receipt of a COVID-19 vaccine within the first 6 months after CVXGA1 study vaccine administration.
- Close contact of anyone known to have SARS-CoV-2 infection within 14 days prior to CVXGA1 study vaccine administration.
- History of COVID-19 diagnosis (positive test for antigen or PCR or antibody) at any time in the past (Group 1), or in the 5 months prior to CVXGA1 study vaccine administration (Groups 2, 3 and 4).
- On current treatment with investigational agents for prophylaxis of COVID-19.
- Plan to travel outside the United States (US) (continental US, Hawaii, and Alaska) from enrollment through 28 days after vaccination.
- Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care.
- Non-ambulatory.
- For subjects of any age, individuals currently working with high risk of exposure to SARS-CoV-2.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Research Your Health
Plano, Texas, 75093
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Phase 1 Open-Label, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of Intranasal Parainfluenza Virus Type 5- SARS CoV-2 S Vaccine (CVXGA1) in Healthy Adults Aged 18 to 55 Years and Adolescents Aged 12 to 17 Years
This Phase 1 trial is an open-label trial to evaluate the safety, reactogenicity and immunogenicity of two dosages (10^6 PFU and 10^7 PFU) of intranasal CVXGA1 administered as a single dose in healthy adults age 18-55 years and in adolescents age 12-17.
Read the detailed description
This is an open-label, dose-ranging phase 1 trial of the PIV5 virus-vectored SARS CoV-2 S glycoprotein vaccine (CVXGA1) in healthy adults (males and nonpregnant females) 18 to 55 years of age that have not had a prior COVID vaccination (Groups 1 and 2), and in healthy adults 18 to 55 years of age (Groups 3) and adolescents 12-17 years of age (Group 4) who have received at least two doses of mRNA-based COVID vaccines (Pfizer Comirnaty® or Moderna Spikevax™) with the last dose at least 5 months prior to planned receipt of CVXGA1 study vaccine. The trial is designed to assess the safety, reactogenicity, and immunogenicity of a single dose of intranasal CVXGA1. Two dose levels will be assessed, CVXGA1-low lose (LD) at 106 plaque-forming units (PFU) (Group 1) and CVXGA1-high dose (HD) at 107 PFU (Groups 2, 3 and 4).
- Conditions
- Covid19
- Being tested
- CVXGA1 low dose, CVXGA1 high dose
- Keywords
- Intranasal Vaccine, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVXGA1 low doseBiological
Also called PIV5-SARS CoV-2 vaccine
see arm/group description
CVXGA1 high doseBiological
Also called PIV5-SARS CoV-2 vaccine
see arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55 | Experimental | Group 1 (Young adults aged 18 to 55 years - CVXGA1- Low Dose, no prior COVID vaccine or infection) Receives: Biological: CVXGA1 low dose |
| Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55 | Experimental | Group 2 (Young adults aged 18 to 55 years - CVXGA1- High Dose, no prior COVID vaccine, no prior COVID vaccine or infection allowed if occurring at least 5 months prior to enrollment) Receives: Biological: CVXGA1 high dose |
| Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55 | Experimental | Group 3 (Young adults aged 18-55 years - CVXGA1 - High Dose, prior receipt of two or more doses of COVID mRNA vaccine (Pfizer Comirnaty® or Moderna Spikevax™) at least 5 months prior to study enrollment. Prior COVID infection allowed if occurring at least 5 months prior to study enrollment). Receives: Biological: CVXGA1 high dose |
| Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17 | Experimental | Group 4 (Adolescents aged 12-17 years - CVXGA1 - High Dose, prior receipt of two or more doses of COVID mRNA vaccine (Pfizer Comirnaty® or Moderna Spikevax™) at least 5 months prior to study enrollment. Prior COVID infection allowed if occuring at least 5 months prior to study enrollment. Receives: Biological: CVXGA1 high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited Adverse Events
Frequencies and grades of solicited local and systemic AEs during a 7-day period after dosing
Measured: Day 1-8
Unsolicited Adverse Events
Frequencies and grades of unsolicited AEs during the 28-day period after dosing
Measured: Day 1-29
Secondary outcomes (6)
Serum IgG titers to SARS-CoV-2 S protein
Geometric mean titer (GMT) of serum IgG titers specific to SARS-CoV-2 spike protein (S)
Measured: Day 29
Percentage of subjects who seroconverted
Percentage of subjects who seroconverted, where seroconversion is defined as a ≥4-fold increase in titer from Baseline (Day 1) of serum IgG titers specific to SARS-CoV-2 spike protein (S)
Measured: Day 29
Change in IgG titers to SARS-CoV-2 S protein
Geometric mean fold rise in titer from Baseline (GMFR) of serum IgG titers specific to SARS-CoV-2 spike protein (S)
Measured: Day 29
Adverse Events within 30 min of dosing
Frequencies of AEs occurring within 30 minutes after dosing
Measured: Day 1
Medically Attended Adverse Events
Frequencies of Medically Attended Adverse Events (MAAEs) from Day 1 to Day 181
Measured: Day 1 - 181
Serious adverse events, new-onset chronic medical conditions, and adverse events of special interest
Frequencies of serious adverse events (SAEs), new-onset chronic medical condition (NOCMCs) and AEs of Special Interest (AESIs)
Measured: Day 1 to Day 366
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start6 Aug 2021
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Progression will be by dose escalation (low dose to high dose) in healthy adults aged 18 to 55 years (N=up to 60), with approximately 12 months' follow-up. Safety data from sentinel subjects (4) will be assessed by a safety monitoring committee (SMC) if halting rules are met for 1) vaccine administration to the remaining subjects within the group, 2) progression from the low dose (1 x 106 PFU) group to the high dose (1 x 107 PFU) groups (without or with prior receipt of COVID vaccine), and 3) progression from the high dose adult group (18 to 55 years) with prior receipt of COVID vaccine to the adolescent (12-17 years) group (N= up to 20) with prior receipt of COVID-19 vaccine.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- CyanVac LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Spearman, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954287
- Sponsor's protocol ID
- CVXGA1-001
- Acronym
- CVXGA1-001
- Status last verified
- Feb 2024
- First submitted
- 30 Jun 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD underlying the results reported in any published articles (text, tables, figures, appendices) will be shared.
Publications
Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
PubMed 36435633
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of Intranasal Parainfluenza Virus Type 5- SARS CoV-2 S Vaccine (CVXGA1) in Healthy Adults Aged 18 to 55 Years and Adolescents Aged 12 to 17 Years
- ClinicalTrials.gov ID
- NCT04954287
- Acronym / sponsor ID
- CVXGA1-001 / CVXGA1-001
- Conditions
- Covid19
- Keywords
- Intranasal Vaccine, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- CyanVac LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 8 Jul 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 Phase 1 trial is an open-label trial to evaluate the safety, reactogenicity and immunogenicity of two dosages (10^6 PFU and 10^7 PFU) of intranasal CVXGA1 administered as a single dose in healthy adults age 18-55 years and in adolescents age 12-17.
Detailed description
This is an open-label, dose-ranging phase 1 trial of the PIV5 virus-vectored SARS CoV-2 S glycoprotein vaccine (CVXGA1) in healthy adults (males and nonpregnant females) 18 to 55 years of age that have not had a prior COVID vaccination (Groups 1 and 2), and in healthy adults 18 to 55 years of age (Groups 3) and adolescents 12-17 years of age (Group 4) who have received at least two doses of mRNA-based COVID vaccines (Pfizer Comirnaty® or Moderna Spikevax™) with the last dose at least 5 months prior to planned receipt of CVXGA1 study vaccine. The trial is designed to assess the safety, reactogenicity, and immunogenicity of a single dose of intranasal CVXGA1. Two dose levels will be assessed, CVXGA1-low lose (LD) at 106 plaque-forming units (PFU) (Group 1) and CVXGA1-high dose (HD) at 107 PFU (Groups 2, 3 and 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Progression will be by dose escalation (low dose to high dose) in healthy adults aged 18 to 55 years (N=up to 60), with approximately 12 months' follow-up. Safety data from sentinel subjects (4) will be assessed by a safety monitoring committee (SMC) if halting rules are met for 1) vaccine administration to the remaining subjects within the group, 2) progression from the low dose (1 x 106 PFU) group to the high dose (1 x 107 PFU) groups (without or with prior receipt of COVID vaccine), and 3) progression from the high dose adult group (18 to 55 years) with prior receipt of COVID vaccine to the adolescent (12-17 years) group (N= up to 20) with prior receipt of COVID-19 vaccine.
| Arm | Type | Receives |
|---|---|---|
| Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55 | Experimental | Biological: CVXGA1 low doseGroup 1 (Young adults aged 18 to 55 years - CVXGA1- Low Dose, no prior COVID vaccine or infection) |
| Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55 | Experimental | Biological: CVXGA1 high doseGroup 2 (Young adults aged 18 to 55 years - CVXGA1- High Dose, no prior COVID vaccine, no prior COVID vaccine or infection allowed if occurring at least 5 months prior to enrollment) |
| Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55 | Experimental | Biological: CVXGA1 high doseGroup 3 (Young adults aged 18-55 years - CVXGA1 - High Dose, prior receipt of two or more doses of COVID mRNA vaccine (Pfizer Comirnaty® or Moderna Spikevax™) at least 5 months prior to study enrollment. Prior COVID infection allowed if occurring at least 5 months prior to study enrollment). |
| Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17 | Experimental | Biological: CVXGA1 high doseGroup 4 (Adolescents aged 12-17 years - CVXGA1 - High Dose, prior receipt of two or more doses of COVID mRNA vaccine (Pfizer Comirnaty® or Moderna Spikevax™) at least 5 months prior to study enrollment. Prior COVID infection allowed if occuring at least 5 months prior to study enrollment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Provide informed consent and assent as applicable prior to initiation of any trial procedures.
- Be able to understand and agrees to comply with planned trial procedures and be available for all trial visits.
- Agrees to the collection of venous blood per protocol.
- Healthy male or non-pregnant female between 12 and 55 years of age inclusive at time of enrollment who are not at high risk of SARS-CoV-2 exposure defined as individuals whose health status, profession, locations or circumstances put them at high risk of exposure to SARS-CoV-2 and COVID-19.
- Body Mass Index (BMI) <40.0 kg/m2 (or < 35.0 kg/m2 if obesity-related health conditions are present) at screening. Subjects must weigh a minimum of 31 kg.
Key exclusion criteria (26 listed)
- Positive pregnancy test either at screening or just prior to vaccine administration.
- Female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination.
- Anyone at high risk of severe COVID-19 disease as per current CDC guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>) or has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes trial participation.* *Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
- Presence of self-reported or medically documented significant medical or psychiatric condition(s).*
- Has an acute illness*, as determined by the participating site PI or appropriate sub- investigator, with or without fever [oral temperature ≥ 38.0° Celsius (100.4° Fahrenheit)] within 72 hours of vaccination. *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
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 |
|---|---|---|
| CVXGA1 low doseAlso: PIV5-SARS CoV-2 vaccinesee arm/group description | Biological | Group 1, 1 x 10^6 PFU CVXGA1 in Ages 18-55 |
| CVXGA1 high doseAlso: PIV5-SARS CoV-2 vaccinesee arm/group description | Biological | Group 2, 1 x 10^7 PFU CVXGA1 in Ages 18-55, Group 3, 1 x 10^7 PFU CVXGA1 in Ages 18-55, Group 4, 1 x 10^7 PFU CVXGA1 in Ages 12-17 |
Primary outcome
Solicited Adverse Events
Time frame: Day 1-8
Frequencies and grades of solicited local and systemic AEs during a 7-day period after dosing
Unsolicited Adverse Events
Time frame: Day 1-29
Frequencies and grades of unsolicited AEs during the 28-day period after dosing
6 secondary outcomes
Serum IgG titers to SARS-CoV-2 S protein
Time frame: Day 29
Percentage of subjects who seroconverted
Time frame: Day 29
Change in IgG titers to SARS-CoV-2 S protein
Time frame: Day 29
Adverse Events within 30 min of dosing
Time frame: Day 1
Medically Attended Adverse Events
Time frame: Day 1 - 181
Serious adverse events, new-onset chronic medical conditions, and adverse events of special interest
Time frame: Day 1 to Day 366
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 36435633Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
- Individual participant dataSharing planned: Yes. De-identified IPD underlying the results reported in any published articles (text, tables, figures, appendices) will be shared.
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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.
Paul Spearman, MD principal investigator
Children's Hospital Medical Center, Cincinnati
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 CVXGA1 low dose and CVXGA1 high dose in people with Covid19, run by CyanVac LLC 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 21 inclusion and 26 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 7 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Solicited Adverse Events (time frame: Day 1-8). The study lists 2 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 NCT04954287, 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 7 Feb 2024.