COVID-19Phase 2NCT06742281
A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults
A Phase 2 study testing CVXGA (CVXGA50) and COMIRNATY® in people with COVID-19, run by CyanVac LLC at 55 sites in United States.
Trial summary
The purpose of this trial is to assess the safety and relative efficacy of CVXGA (CVXGA50), a KP.2 containing vaccine, compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula), a currently approved COVID-19 vaccine in the prevention of symptomatic, RT-PCR-confirmed SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- CVXGA (CVXGA50) and COMIRNATY®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 55 sitesUnited States
- Study dates
- 5 Dec 2024to 15 Jun 2026
- Phase
- Phase 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is an adult ≥18 years of age at time of screening.
- Has completed any WHO/FDA-authorized or approved primary COVID-19 vaccination series.
- Has received last COVID-19 vaccine no less than 6 months prior to study enrollment (study vaccination).
- If a female of childbearing potential who is sexually active, agrees to use an adequate method of birth control from Screening through 90 days after last study vaccination, and has used an adequate birth control method for at least 30 days prior to Screening.
- Female of childbearing potential is defined as post onset menarche and pre-menopausal person capable of becoming pregnant. This does not include females who meet any of the following conditions: a) menopausal >2 years; b) tubal ligation >1 year; c) bilateral salpingo-oophorectomy; or d) hysterectomy.
- Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label. Examples include: oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; the female participant has exclusively female sexual partners; partner is sterile or otherwise unable to produce sperm (information on the person's sterility can come from the site personnel's review of the participant's medical records or interview with the participant regarding her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); or male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).
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- Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical examination).
- Agrees to not participate in any other SARS-CoV-2 infection prevention trial (vaccine, drug, biologic, or pre-exposure prophylaxis [PrEP]) during participation in the study.
- Willing and able to provide informed consent prior to initiation of study procedures.
- Is available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study.
Who cannot join
- Has an acute illness, as determined by the site investigator, within 72 hours prior to Screening or study vaccination.
- An acute illness that is nearly resolved, with only minor residual symptoms remaining, is allowable if, in the opinion of the site investigator, the residual symptoms will not interfere with the ability of study staff to assess safety parameters as required by the protocol.)
- Has had a positive COVID-19 test within the 90 days prior to Screening or study vaccination.
- Current or planned participation in any other interventional clinical trial.
- Prior receipt of a PIV5-based vaccine (e.g., CVXGA1, CVXGA35, or BLB201 [an RSV vaccine being developed by CyanVac/Blue Lake Biotechnology]).
- Participation in research involving any investigational product within 45 days prior to Screening or study vaccination.
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- Receipt of any approved or authorized products intended to prevent SARS-CoV-2 infection within 6 months prior to Screening (complete list provided in the pharmacy manual).
- Receipt or anticipated receipt of, within 7 days prior through 31 days after study vaccination, any intranasal medication including FDA approved prescription or over-the-counter products or non-FDA approved alternative medicine products (e.g., intranasal Fluticasone {commonly used intranasal products that would be used, which is not herbal/naturopathic}, Ayurvedic oil or other naturopathic substances).
- Anticipated use of nasal irrigation (e.g., Neti PotTM) from Screening through 31 days after study vaccination.
- Receipt of blood products or immunoglobulins within 60 days prior to Screening or study vaccination.
- Received influenza vaccination within 14 days prior to Screening or study vaccination, or any other vaccine within 30 days prior to Screening or study vaccination.
- Any significant or uncontrolled autoimmune, immunodeficiency disease/condition, or autoinflammatory disorder (e.g. untreated or advanced human immunodeficiency virus [HIV] infection with CD4 counts <200 cells/mm3, history of acquired immunodeficiency syndrome [AIDS] defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV).
- Unstable illness (acute or chronic illness) requiring significant medical monitoring and intervention during the 90 days prior to Screening or study vaccination.
- History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that, in the opinion of the investigator, increases risk of myocarditis or pericarditis.
- Administration of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within the following timeframes:
- B-cell therapies within the 6 months prior to Screening or study vaccination.
- Prednisone, ≥20 mg for more than 2 weeks, within the 30 days prior to Screening or study vaccination.
- Monoclonal antibodies that may suppress aspects of immune response (e.g., Dupixent) within the 6 months prior to Screening or study vaccination.
- Other medications in this category, including but not limited to high-dose inhaled corticosteroids (>800 mcg/day of beclomethasone dipropionate or equivalent); antimetabolites; transplant immunosuppressive agents; alkylating agents; cell-depleting agents; or cancer chemotherapeutics, within the 90 days prior to Screening or study vaccination.
- Any medication for any period of time that, in the opinion of the site investigator, could impede immune response to vaccination.
- Individuals who have close contact or high-risk contact with persons who may be severely immunocompromised, within 14 days following the study vaccination. High-risk contacts include but are not limited to:
- Residents of nursing homes or rehabilitation facilities
- Persons of any age with any significant immunodeficiency disease (e.g., untreated or advanced HIV, history of AIDS, or clinical manifestations of HIV)
- Persons of any age being administered immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs
- Persons of any age with a known history of significant airway reactivity to viruses (e.g., severe asthma, advanced chronic obstructive disease, or cystic fibrosis)
- Persons of any age immunosuppressed due to cancer or undergoing active treatment for cancer
- Women who are pregnant, breastfeeding, or who plan to become pregnant during the study; and
- Infants age ≤6 months.
- Known contraindication to IM injection (e.g., bleeding diathesis, acquired coagulopathy) or to intranasal administration (e.g., severe nasal obstruction, significant chronic rhinitis, nasal septal defect causing significant breathing problems, unrepaired cleft palate, nasal polyps, or other nasal abnormality that, in the opinion of the investigator, may affect vaccine administration).
- History of significant/severe wheezing or respiratory symptoms resulting in hospitalization or known bronchial hyperreactivity to viruses.
- History of severe adverse reaction to vaccination in the past, including to COVID-19 vaccination.
- Any known allergies to components contained in CVXGA or COMIRNATY (including polyethylene glycol [PEG] allergies), or latex.
- Women who are pregnant, breastfeeding, or who plan to become pregnant during the study.
- Any other condition that, in the opinion of the site investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the investigational product or interpretation of study results.
- Study team member or first-degree relative of any study team member (inclusive of CyanVac and site personnel involved in the study).
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Avacare
Austin, Texas, 78705
Tekton Research, LLC
Austin, Texas, 78745
Velocity Clinical Research, Austin
Austin, Texas, 78759
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
Velocity Clinical Research, Binghamton
Binghamton, New York, 13905
Pan American Clinical Research, LLC
Brownsville, Texas, 78520
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio, 45219
Velocity Clinical Research, Springdale
Cincinnati, Ohio, 45246
Velocity Clinical Research, Covington
Covington, Louisiana, 70433
Avacare
Fort Worth, Texas, 76135
Velocity Clinical Research Gaffney
Gaffney, South Carolina, 29340
CBH Health
Gaithersburg, Maryland, 20877
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009
Homestead Associates in Research, Inc
Homestead, Florida, 33033
DM Clinical Research
Houston, Texas, 77065
DM Clinical Research
Houston, Texas, 77081
DM Clinical Research
Jersey City, New Jersey, 07306
Velocity Clinical Research, San Diego
La Mesa, California, 91942
Imax Clinical Trials
La Palma, California, 90623
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, 70508
Lifeline Primary Care/Avacare
Lilburn, Georgia, 30047
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
Velocity Clinical Research, New Orleans
New Orleans, Louisiana, 70119
Velocity Clinical Research - Norfolk
Norfolk, Nebraska, 68701
Biscayne Clinical Research
North Miami Beach, Florida, 33169
Quality Clinical Research, Inc
Omaha, Nebraska, 68114
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
Headlands Research Orlando
Orlando, Florida, 32819
Best Choice Medical and Research Service
Pembroke Pines, Florida, 33024
DM Clinical Research
Philadelphia, Pennsylvania, 19107
Velocity Clinical Research, Phoenix
Phoenix, Arizona, 85006
Clinical Research Partners LLC
Richmond, Virginia, 23226
Artemis Institute for Clinical Research
Riverside, California, 92503
Clinical Innovations Inc. dba CITrials
Riverside, California, 92506
Rochester Clinical Research
Rochester, New York, 14609
Advanced Primary and Geriatric Care/Avacare
Rockville, Maryland, 20850
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
Avacare
Sacramento, California, 95864
Avacare
San Angelo, Texas, 76904
Tekton Research, LLC
San Antonio, Texas, 78229
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106
DM Clinical Research
Southfield, Michigan, 48076
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Velocity Clinical Research, Suffolk
Suffolk, Virginia, 23435
Forcare Clinical Research
Tampa, Florida, 33613
Guardian Angel Research Center
Tampa, Florida, 33614
Collaborative Neuroscience Research, LLC
Torrance, California, 90504
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, 20016
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
Tekton Research, LLC
Yukon, Oklahoma, 73099
About this study
Official title: A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA (CVXGA50) Intranasal COVID-19 Vaccine in Adults
The purpose of this trial is to assess the safety and relative efficacy of CVXGA (CVXGA50), a KP.2 containing vaccine, compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula), a currently approved COVID-19 vaccine in the prevention of symptomatic, RT-PCR-confirmed SARS-CoV-2 infection. The trial will enroll up to 434 healthy participants.
Read the detailed description
This is a double-blind, active comparator-controlled Phase 2b study to evaluate the efficacy, immunogenicity, and safety study in which eligible adult participants will be randomized 1:1 to receive CVXGA (CVXGA50) or COMIRNATY.
Number of Participants:
The proposed enrollment for this study is approximately 434 participants, that includes 16 participants enrolled in Sentinel Cohort 1 and Sentinel Cohort 2 (8 participants in each cohort).
Treatment Assignment:
Participants in Sentinel Cohort 1 and Sentinel Cohort 2 will be assigned to receive a single dose of CVXGA (CVXGA50) intranasally and will not receive an IM placebo.
All other participants in the study will be randomized 1:1 to receive a single dose of CVXGA (CVXGA50) intranasally (plus a single dose of IM placebo), or a single dose of IM COMIRNATY (plus a single dose of intranasal placebo).
Study visits: Participants will be asked to complete approximately 6-7 clinic visits, over a period of approximately 12 months duration per participant.
- Conditions
- COVID-19
- Being tested
- CVXGA (CVXGA50), COMIRNATY®
- Keywords
- COVID-19 intranasal 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.
CVXGA (CVXGA50)Biological
CVXGA is a recombinant parainfluenza virus type 5 (PIV5) engineered to express SARS-CoV-2 S gene from the KP.2 strain.
COMIRNATY®Biological
COMIRNATY® (COVID-19 vaccine, mRNA) suspension for injection, for intramuscular use, 2024-2025 Formula (BioNTech Manufacturing GmbH [Mainz, Germany] and Pfizer Inc. [New York, NY]) will be used as the comparator vaccine for this study.
| Study group | Role | What they receive |
|---|---|---|
| CVXGA (CVXGA50) | Experimental | CVXGA is a recombinant parainfluenza virus type 5 (PIV5) engineered to express SARS-CoV-2 S gene from the KP.2 strain. Receives: Biological: CVXGA (CVXGA50) |
| COMIRNATY® | Active comparator | COMIRNATY® (COVID-19 vaccine, mRNA) suspension for injection, for intramuscular use, 2024-2025 Formula (BioNTech Manufacturing GmbH [Mainz, Germany] and Pfizer Inc. [New York, NY]) will be used as the comparator vaccine for this study. Receives: Biological: COMIRNATY® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with symptomatic COVID-19 after boost with CVXGA (CVXGA50) compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula) to compare differences in relative vaccine efficacy.
First occurrence of molecularly confirmed (RT-PCR-positive) symptomatic COVID-19 according to the case definition with onset at least 14 days post-vaccination through 12 months post-vaccination.
Case definition: Virologically confirmed SARS-CoV-2 infection (by RT-PCR) with 1 or more of the following symptoms within ±7 days:
- Fever or chills
- Cough
- Shortness of breath or difficulty breathing
- Fatigue
- Muscle or body aches
- Headache
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
Measured: Day 14 to Day 366 post-vaccination.
Secondary outcomes (16)
Time until first occurrence of molecularly confirmed (RT-PCR-positive) symptomatic COVID-19 for CVXGA (CVXGA50) compared to COMIRNATY to determine durability
First occurrence of molecularly confirmed (RT-PCR-positive) symptomatic COVID-19 according to the case definition with onset at least 14 days post-vaccination through 12 months post-vaccination evaluated separately in 0-6- and 6-12- month time periods.
Measured: Day 1 to Day 366 post-vaccination.
Percentage of participants with asymptomatic COVID-19 after boost with CVXGA (CVXGA50) compared to COMIRNATY to determine relative efficacy.
First occurrence of molecularly confirmed (RT-PCR -positive) asymptomatic COVID-19 from 14 days post-vaccination through 12 months post-vaccination.
Measured: Day 14 to Day 366 post-vaccination.
Percentage of participants with severe COVID-19 after boost with CVXGA (CVXGA50) compared to COMIRNATY to determine relative efficacy.
First occurrence of molecularly confirmed (RT-PCR-positive) severe COVID-19 according to the case definition from 14 days post-vaccination through 12 months post-vaccination.
Case definition: Virologically confirmed SARS-CoV-2 infection (by RT-PCR) with any of the following:
- Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room air or PaO2/FiO2 <300 mm Hg)
- Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation [ECMO])
- Evidence of shock (systolic blood pressure [SBP] <90 mm Hg, diastolic blood pressure [DBP] <60 mm Hg, or requiring vasopressors)
- Significant acute renal, hepatic, or neurologic dysfunction
- Admission to an intensive care unit (ICU)
- Death
Measured: Day 14 to Day 366 post-vaccination.
The percentage of participants who experience any solicited local reactogenicity symptom pertaining to intranasal administration through 7 days post-vaccination.
The percentage of participants who experience any solicited local reactogenicity symptom pertaining to intranasal administration through 7 days post-vaccination.
Measured: Time Frame: Day 1 to Day 7 post-vaccination.
The percentage of participants who experience any solicited local reactogenicity symptom pertaining to intramuscular (IM) administration through 7 days post-vaccination.
The percentage of participants who experience any solicited local reactogenicity symptom pertaining to intramuscular (IM) administration through 7 days post-vaccination.
Measured: Day 1 to Day 7 post-vaccination.
The percentage of participants who experience any solicited systemic reactogenicity symptom through 7 days post-vaccination.
The percentage of participants who experience any solicited systemic reactogenicity symptom through 7 days post-vaccination.
Measured: Day 1 to Day 7 post-vaccination.
The percentage of participants who experience any unsolicited adverse event (AE) through 30 days post-vaccination.
The percentage of participants who experience any unsolicited adverse event (AE) through 30 days post-vaccination.
Measured: Day 1 to Day 30 post-vaccination.
The percentage of participants who experience the following events through 12 months post-vaccination: o serious adverse events (SAEs) o medically attended adverse events (MAAEs) o adverse events of special interest (AESIs)
The percentage of participants who experience the following events through 12 months post-vaccination:
- serious adverse events (SAEs)
- medically attended adverse events (MAAEs)
- adverse events of special interest (AESIs)
Measured: Day 1 to Day 366 post-vaccination.
The percentage of participants with any new or worsening clinically significant abnormal safety laboratory result (serum chemistries and hematology) through 7 days post-vaccination.
The percentage of participants with any new or worsening clinically significant abnormal safety laboratory result (serum chemistries and hematology) through 7 days post-vaccination.
Measured: Day 1 to Day 7 post-vaccination.
Geometric mean titer (GMT) of SARS-CoV-2 specific neutralizing antibody (nAb) at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
Geometric mean titer (GMT) of SARS-CoV-2 specific neutralizing antibody (nAb) at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
Measured: Day 1 to Day 366 post-vaccination.
Geometric mean fold rise (GMFR) of SARS-CoV-2 specific nAb relative to Day 1 at Days 31, 91, 181, and 366 post-vaccination.
Geometric mean fold rise (GMFR) of SARS-CoV-2 specific nAb relative to Day 1 at Days 31, 91, 181, and 366 post-vaccination.
Measured: Day 1 to Day 366 post-vaccination.
GMT of anti-spike (S) protein-specific binding antibody (bAb) at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
GMT of anti-spike (S) protein-specific binding antibody (bAb) at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
Measured: Day 1 to Day 366 post-vaccination.
GMFR of S protein-specific bAb relative to Day 1 at Days 31, 91, 181, and 366 post-vaccination.
GMFR of S protein-specific bAb relative to Day 1 at Days 31, 91, 181, and 366 post-vaccination.
Measured: Day 1 to Day 366 post-vaccination.
GMT of S protein-specific IgA (nasal lining/saliva samples) at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
GMT of S protein-specific IgA (nasal lining/saliva samples) at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
Measured: Day 1 to Day 366 post-vaccination.
GMFR of S protein-specific IgA (nasal lining/saliva samples) relative to Day 1 at Days 31, 91, 181, and 366 post-vaccination.
GMFR of S protein-specific IgA (nasal lining/saliva samples) relative to Day 1 at Days 31, 91, 181, and 366 post-vaccination.
Measured: Day 1 to Day 366 post-vaccination.
The percentage of subjects with increases in S-specific cytokine increases by cell type.
Intracellular cytokine and cell surface marker staining at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
Measured: Day 1 to Day 366 post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start5 Dec 2024
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- CyanVac LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Hong Jin, Principal investigator, CyanVac LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742281
- Sponsor's protocol ID
- CVXGA-003
- Other IDs
- 24-04-NGVx-002
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA (CVXGA50) Intranasal COVID-19 Vaccine in Adults
- ClinicalTrials.gov ID
- NCT06742281
- Acronym / sponsor ID
- CVXGA-003
- Conditions
- COVID-19
- Keywords
- COVID-19 intranasal vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- CyanVac LLCIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 19 Dec 2024 (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.
The purpose of this trial is to assess the safety and relative efficacy of CVXGA (CVXGA50), a KP.2 containing vaccine, compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula), a currently approved COVID-19 vaccine in the prevention of symptomatic, RT-PCR-confirmed SARS-CoV-2 infection. The trial will enroll up to 434 healthy participants.
Detailed description
This is a double-blind, active comparator-controlled Phase 2b study to evaluate the efficacy, immunogenicity, and safety study in which eligible adult participants will be randomized 1:1 to receive CVXGA (CVXGA50) or COMIRNATY.
Number of Participants:
The proposed enrollment for this study is approximately 434 participants, that includes 16 participants enrolled in Sentinel Cohort 1 and Sentinel Cohort 2 (8 participants in each cohort).
Treatment Assignment:
Participants in Sentinel Cohort 1 and Sentinel Cohort 2 will be assigned to receive a single dose of CVXGA (CVXGA50) intranasally and will not receive an IM placebo.
All other participants in the study will be randomized 1:1 to receive a single dose of CVXGA (CVXGA50) intranasally (plus a single dose of IM placebo), or a single dose of IM COMIRNATY (plus a single dose of intranasal placebo).
Study visits: Participants will be asked to complete approximately 6-7 clinic visits, over a period of approximately 12 months duration per participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVXGA (CVXGA50) | Experimental | Biological: CVXGA (CVXGA50)CVXGA is a recombinant parainfluenza virus type 5 (PIV5) engineered to express SARS-CoV-2 S gene from the KP.2 strain. |
| COMIRNATY® | Active comparator | Biological: COMIRNATY®COMIRNATY® (COVID-19 vaccine, mRNA) suspension for injection, for intramuscular use, 2024-2025 Formula (BioNTech Manufacturing GmbH [Mainz, Germany] and Pfizer Inc. [New York, NY]) will be used as the comparator vaccine for this study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is an adult ≥18 years of age at time of screening.
- Has completed any WHO/FDA-authorized or approved primary COVID-19 vaccination series.
- Has received last COVID-19 vaccine no less than 6 months prior to study enrollment (study vaccination).
- If a female of childbearing potential who is sexually active, agrees to use an adequate method of birth control from Screening through 90 days after last study vaccination, and has used an adequate birth control method for at least 30 days prior to Screening.
- Female of childbearing potential is defined as post onset menarche and pre-menopausal person capable of becoming pregnant. This does not include females who meet any of the following conditions: a) menopausal >2 years; b) tubal ligation >1 year; c) bilateral salpingo-oophorectomy; or d) hysterectomy.
Key exclusion criteria (35 listed)
- Has an acute illness, as determined by the site investigator, within 72 hours prior to Screening or study vaccination.
- Has had a positive COVID-19 test within the 90 days prior to Screening or study vaccination.
- Current or planned participation in any other interventional clinical trial.
- Prior receipt of a PIV5-based vaccine (e.g., CVXGA1, CVXGA35, or BLB201 [an RSV vaccine being developed by CyanVac/Blue Lake Biotechnology]).
- Participation in research involving any investigational product within 45 days prior to Screening or study vaccination.
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 |
|---|---|---|
| CVXGA (CVXGA50)CVXGA is a recombinant parainfluenza virus type 5 (PIV5) engineered to express SARS-CoV-2 S gene from the KP.2 strain. | Biological | CVXGA (CVXGA50) |
| COMIRNATY®COMIRNATY® (COVID-19 vaccine, mRNA) suspension for injection, for intramuscular use, 2024-2025 Formula (BioNTech Manufacturing GmbH [Mainz, Germany] and Pfizer Inc. [New York, NY]) will be used as the comparator vaccine for this study. | Biological | COMIRNATY® |
Primary outcome
Percentage of participants with symptomatic COVID-19 after boost with CVXGA (CVXGA50) compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula) to compare differences in relative vaccine efficacy.
Time frame: Day 14 to Day 366 post-vaccination.
First occurrence of molecularly confirmed (RT-PCR-positive) symptomatic COVID-19 according to the case definition with onset at least 14 days post-vaccination through 12 months post-vaccination. Case definition: Virologically confirmed SARS-CoV-2 infection (by RT-PCR) with 1 or more of the following symptoms within ±7 days: * Fever or chills * Cough * Shortness of breath or difficulty breathing * Fatigue * Muscle or body aches * Headache * New loss of taste or smell * Sore throat * Congestion or runny nose * Nausea or vomiting * Diarrhea
16 secondary outcomes
Time until first occurrence of molecularly confirmed (RT-PCR-positive) symptomatic COVID-19 for CVXGA (CVXGA50) compared to COMIRNATY to determine durability
Time frame: Day 1 to Day 366 post-vaccination.
Percentage of participants with asymptomatic COVID-19 after boost with CVXGA (CVXGA50) compared to COMIRNATY to determine relative efficacy.
Time frame: Day 14 to Day 366 post-vaccination.
Percentage of participants with severe COVID-19 after boost with CVXGA (CVXGA50) compared to COMIRNATY to determine relative efficacy.
Time frame: Day 14 to Day 366 post-vaccination.
The percentage of participants who experience any solicited local reactogenicity symptom pertaining to intranasal administration through 7 days post-vaccination.
Time frame: Time Frame: Day 1 to Day 7 post-vaccination.
The percentage of participants who experience any solicited local reactogenicity symptom pertaining to intramuscular (IM) administration through 7 days post-vaccination.
Time frame: Day 1 to Day 7 post-vaccination.
The percentage of participants who experience any solicited systemic reactogenicity symptom through 7 days post-vaccination.
Time frame: Day 1 to Day 7 post-vaccination.
The percentage of participants who experience any unsolicited adverse event (AE) through 30 days post-vaccination.
Time frame: Day 1 to Day 30 post-vaccination.
The percentage of participants who experience the following events through 12 months post-vaccination: o serious adverse events (SAEs) o medically attended adverse events (MAAEs) o adverse events of special interest (AESIs)
Time frame: Day 1 to Day 366 post-vaccination.
The percentage of participants with any new or worsening clinically significant abnormal safety laboratory result (serum chemistries and hematology) through 7 days post-vaccination.
Time frame: Day 1 to Day 7 post-vaccination.
Geometric mean titer (GMT) of SARS-CoV-2 specific neutralizing antibody (nAb) at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
Time frame: Day 1 to Day 366 post-vaccination.
Geometric mean fold rise (GMFR) of SARS-CoV-2 specific nAb relative to Day 1 at Days 31, 91, 181, and 366 post-vaccination.
Time frame: Day 1 to Day 366 post-vaccination.
GMT of anti-spike (S) protein-specific binding antibody (bAb) at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
Time frame: Day 1 to Day 366 post-vaccination.
GMFR of S protein-specific bAb relative to Day 1 at Days 31, 91, 181, and 366 post-vaccination.
Time frame: Day 1 to Day 366 post-vaccination.
GMT of S protein-specific IgA (nasal lining/saliva samples) at Day 1 and Days 31, 91, 181, and 366 post-vaccination.
Time frame: Day 1 to Day 366 post-vaccination.
GMFR of S protein-specific IgA (nasal lining/saliva samples) relative to Day 1 at Days 31, 91, 181, and 366 post-vaccination.
Time frame: Day 1 to Day 366 post-vaccination.
The percentage of subjects with increases in S-specific cytokine increases by cell type.
Time frame: Day 1 to Day 366 post-vaccination.
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Hong Jin principal investigator
CyanVac LLC
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVXGA (CVXGA50) and COMIRNATY® in people with COVID-19, run by CyanVac LLC at 55 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 10 inclusion and 35 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 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 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 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?
Percentage of participants with symptomatic COVID-19 after boost with CVXGA (CVXGA50) compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula) to compare differences in relative vaccine efficacy. (time frame: Day 14 to Day 366 post-vaccination.). 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 13 Oct 2026.