Loading clinical trials...

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

ACTIVE_NOT_RECRUITINGPHASE2

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

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

NCT06742281•CyanVac LLC

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.
+25 more criteria

Locations (55)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Velocity Clinical Research, Phoenix

Phoenix, Arizona, United States

Velocity Clinical Research, Chula Vista

Chula Vista, California, United States

Velocity Clinical Research, San Diego

La Mesa, California, United States

Imax Clinical Trials

La Palma, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Clinical Innovations Inc. dba CITrials

Riverside, California, United States

Avacare

Sacramento, California, United States

Collaborative Neuroscience Research, LLC

Torrance, California, United States

Velocity Clinical Research, Washington DC

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

Key Dates

Start Date

December 5, 2024

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2027

Last Updated

November 5, 2025

Enrollment

432

ACTUAL participants

Conditions

COVID-19

Interventions

CVXGA (CVXGA50)

BIOLOGICAL

COMIRNATY®

BIOLOGICAL

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

View study

RECRUITINGPHASE1

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Dime La VerDAD: Verify, Debunk, and Disseminate

Positron Emission Tomography (PET) Imaging of Thrombosis