A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults

NCT06742281 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CVXGA-003
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 55

Brief 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. The trial will enroll up to 434 healthy participants.

Conditions

COVID-19

Keywords

COVID-19 intranasal vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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.

  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.

  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: 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.

  Day 1 to Day 7 post-vaccination.

Study Arms (2)

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.

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.

Biological: COMIRNATY®

Interventions

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.

CVXGA (CVXGA50)

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.

COMIRNATY®

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A. 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.
• B. 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).
• 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.

You may not qualify if:

• Has an acute illness, as determined by the site investigator, within 72 hours prior to Screening or study vaccination.
• (a. 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.
• 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:

Sponsors & Collaborators

• CyanVac LLC: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (55)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Velocity Clinical Research, Phoenix

Phoenix, Arizona, 85006, United States

Location

Velocity Clinical Research, Chula Vista

Chula Vista, California, 91911, United States

Location

Velocity Clinical Research, San Diego

La Mesa, California, 91942, United States

Location

Imax Clinical Trials

La Palma, California, 90623, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Clinical Innovations Inc. dba CITrials

Riverside, California, 92506, United States

Location

Avacare

Sacramento, California, 95864, United States

Location

Collaborative Neuroscience Research, LLC

Torrance, California, 90504, United States

Location

Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia, 20016, United States

Location

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States

Location

Homestead Associates in Research, Inc

Homestead, Florida, 33033, United States

Location

Biscayne Clinical Research

North Miami Beach, Florida, 33169, United States

Location

Headlands Research Orlando

Orlando, Florida, 32819, United States

Location

Best Choice Medical and Research Service

Pembroke Pines, Florida, 33024, United States

Location

Forcare Clinical Research

Tampa, Florida, 33613, United States

Location

Guardian Angel Research Center

Tampa, Florida, 33614, United States

Location

Lifeline Primary Care/Avacare

Lilburn, Georgia, 30047, United States

Location

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Velocity Clinical Research, Boise

Meridian, Idaho, 83642, United States

Location

Velocity Clinical Research, Sioux City

Sioux City, Iowa, 51106, United States

Location

Velocity Clinical Research, Covington

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, 70508, United States

Location

Velocity Clinical Research, New Orleans

New Orleans, Louisiana, 70119, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

Advanced Primary and Geriatric Care/Avacare

Rockville, Maryland, 20850, United States

Location

Velocity Clinical Research, Rockville

Rockville, Maryland, 20854, United States

Location

DM Clinical Research

Southfield, Michigan, 48076, United States

Location

Velocity Clinical Research - Norfolk

Norfolk, Nebraska, 68701, United States

Location

Quality Clinical Research, Inc

Omaha, Nebraska, 68114, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

DM Clinical Research

Jersey City, New Jersey, 07306, United States

Location

Velocity Clinical Research, Binghamton

Binghamton, New York, 13905, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States

Location

Velocity Clinical Research, Cleveland

Beachwood, Ohio, 44122, United States

Location

Velocity Clinical Research, Mt. Auburn

Cincinnati, Ohio, 45219, United States

Location

Velocity Clinical Research, Springdale

Cincinnati, Ohio, 45246, United States

Location

Tekton Research, LLC

Yukon, Oklahoma, 73099, United States

Location

DM Clinical Research

Philadelphia, Pennsylvania, 19107, United States

Location

Velocity Clinical Research, Anderson

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research Gaffney

Gaffney, South Carolina, 29340, United States

Location

Avacare

Austin, Texas, 78705, United States

Location

Tekton Research, LLC

Austin, Texas, 78745, United States

Location

Velocity Clinical Research, Austin

Austin, Texas, 78759, United States

Location

Pan American Clinical Research, LLC

Brownsville, Texas, 78520, United States

Location

Avacare

Fort Worth, Texas, 76135, United States

Location

DM Clinical Research

Houston, Texas, 77065, United States

Location

DM Clinical Research

Houston, Texas, 77081, United States

Location

Avacare

San Angelo, Texas, 76904, United States

Location

Tekton Research, LLC

San Antonio, Texas, 78229, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Clinical Research Partners LLC

Richmond, Virginia, 23226, United States

Location

Velocity Clinical Research, Suffolk

Suffolk, Virginia, 23435, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Hong Jin

  CyanVac LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 19, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (55)