A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA (CVXGA50) Intranasal COVID-19 Vaccine in Adults

Status: Recruiting
Location: See all (55) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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 10016 healthy participants.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:

• 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.

Locations
United States
Alabama
Pinnacle Research Group, LLC
RECRUITING
Anniston
Arizona
Velocity Clinical Research, Phoenix
RECRUITING
Phoenix
California
Velocity Clinical Research, Chula Vista
RECRUITING
Chula Vista
Velocity Clinical Research, San Diego
RECRUITING
La Mesa
Imax Clinical Trials
RECRUITING
La Palma
Artemis Institute for Clinical Research
RECRUITING
Riverside
Clinical Innovations Inc. dba CITrials
RECRUITING
Riverside
Avacare
RECRUITING
Sacramento
Collaborative Neuroscience Research, LLC
RECRUITING
Torrance
Washington, D.c.
Velocity Clinical Research, Washington DC
RECRUITING
Washington D.c.
Florida
Velocity Clinical Research, Hallandale Beach
RECRUITING
Hallandale
Homestead Associates in Research, Inc
RECRUITING
Homestead
Biscayne Clinical Research
RECRUITING
North Miami Beach
Headlands Research Orlando
RECRUITING
Orlando
Best Choice Medical and Research Service
RECRUITING
Pembroke Pines
Forcare Clinical Research
RECRUITING
Tampa
Guardian Angel Research Center
RECRUITING
Tampa
Georgia
Lifeline Primary Care/Avacare
RECRUITING
Lilburn
Velocity Clinical Research, Savannah
RECRUITING
Savannah
Clinical Research Atlanta
RECRUITING
Stockbridge
Iowa
Velocity Clinical Research, Sioux City
RECRUITING
Sioux City
Idaho
Velocity Clinical Research, Boise
RECRUITING
Meridian
Louisiana
Velocity Clinical Research, Covington
RECRUITING
Covington
Velocity Clinical Research, Lafayette
RECRUITING
Lafayette
Velocity Clinical Research, New Orleans
RECRUITING
New Orleans
Maryland
CBH Health
RECRUITING
Gaithersburg
Advanced Primary and Geriatric Care/Avacare
RECRUITING
Rockville
Velocity Clinical Research, Rockville
RECRUITING
Rockville
Michigan
DM Clinical Research
RECRUITING
Southfield
North Carolina
Trial Management Associates, LLC
RECRUITING
Wilmington
Nebraska
Velocity Clinical Research - Norfolk
RECRUITING
Norfolk
Quality Clinical Research, Inc
RECRUITING
Omaha
Velocity Clinical Research, Omaha
RECRUITING
Omaha
New Jersey
DM Clinical Research
RECRUITING
Jersey City
New York
Velocity Clinical Research, Binghamton
RECRUITING
Binghamton
Rochester Clinical Research
RECRUITING
Rochester
Ohio
Velocity Clinical Research, Cleveland
RECRUITING
Beachwood
Velocity Clinical Research, Mt. Auburn
RECRUITING
Cincinnati
Velocity Clinical Research, Springdale
RECRUITING
Cincinnati
Oklahoma
Tekton Research, LLC
RECRUITING
Yukon
Pennsylvania
DM Clinical Research
RECRUITING
Philadelphia
South Carolina
Velocity Clinical Research, Anderson
RECRUITING
Anderson
Velocity Clinical Research Gaffney
RECRUITING
Gaffney
Texas
Avacare
RECRUITING
Austin
Tekton Research, LLC
RECRUITING
Austin
Velocity Clinical Research, Austin
RECRUITING
Austin
Pan American Clinical Research, LLC
RECRUITING
Brownsville
Avacare
RECRUITING
Fort Worth
DM Clinical Research
RECRUITING
Houston
DM Clinical Research
RECRUITING
Houston
Avacare
RECRUITING
San Angelo
Tekton Research, LLC
RECRUITING
San Antonio
Utah
Velocity Clinical Research, Salt Lake City
RECRUITING
West Jordan
Virginia
Clinical Research Partners LLC
RECRUITING
Richmond
Velocity Clinical Research, Suffolk
RECRUITING
Suffolk
Contact Information
Primary
Henry Radziewicz, MD
HRadziewicz@cyanvacllc.com
706-201-7798
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2027-06
Participants
Target number of participants: 10016
Treatments
Experimental: CVXGA (CVXGA50)
CVXGA is a recombinant parainfluenza virus type 5 (PIV5) engineered to express SARS-CoV-2 S gene from the KP.2 strain.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Biomedical Advanced Research and Development Authority
Leads: CyanVac LLC

This content was sourced from clinicaltrials.gov