A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults
Purpose
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.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- All
- Accepts 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. - 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: 1. B-cell therapies within the 6 months prior to Screening or study vaccination. 2. Prednisone, ≥20 mg for more than 2 weeks, within the 30 days prior to Screening or study vaccination. 3. Monoclonal antibodies that may suppress aspects of immune response (e.g., Dupixent) within the 6 months prior to Screening or study vaccination. 4. 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. 5. 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: 1. Residents of nursing homes or rehabilitation facilities 2. Persons of any age with any significant immunodeficiency disease (e.g., untreated or advanced HIV, history of AIDS, or clinical manifestations of HIV) 3. Persons of any age being administered immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs 4. 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) 5. Persons of any age immunosuppressed due to cancer or undergoing active treatment for cancer 6. Women who are pregnant, breastfeeding, or who plan to become pregnant during the study; and 7. 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).
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Pinnacle Research Group, LLC
Anniston, Alabama 36207
Anniston, Alabama 36207
Velocity Clinical Research, Phoenix
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Velocity Clinical Research, Chula Vista
Chula Vista, California 91911
Chula Vista, California 91911
Velocity Clinical Research, San Diego
La Mesa, California 91942
La Mesa, California 91942
Imax Clinical Trials
La Palma, California 90623
La Palma, California 90623
Artemis Institute for Clinical Research
Riverside, California 92503
Riverside, California 92503
Clinical Innovations Inc. dba CITrials
Riverside, California 92506
Riverside, California 92506
Collaborative Neuroscience Research, LLC
Torrance, California 90504
Torrance, California 90504
Velocity Clinical Research, Washington DC
Washington, District of Columbia 20016
Washington, District of Columbia 20016
Velocity Clinical Research, Hallandale Beach
Hallandale Beach, Florida 33009
Hallandale Beach, Florida 33009
Homestead Associates in Research, Inc
Homestead, Florida 33033
Homestead, Florida 33033
Biscayne Clinical Research
North Miami Beach, Florida 33169
North Miami Beach, Florida 33169
Headlands Research Orlando
Orlando, Florida 32819
Orlando, Florida 32819
Best Choice Medical and Research Service
Pembroke Pines, Florida 33024
Pembroke Pines, Florida 33024
Forcare Clinical Research
Tampa, Florida 33613
Tampa, Florida 33613
Guardian Angel Research Center
Tampa, Florida 33614
Tampa, Florida 33614
Lifeline Primary Care/Avacare
Lilburn, Georgia 30047
Lilburn, Georgia 30047
Velocity Clinical Research, Savannah
Savannah, Georgia 31406
Savannah, Georgia 31406
Clinical Research Atlanta
Stockbridge, Georgia 30281
Stockbridge, Georgia 30281
Velocity Clinical Research, Boise
Meridian, Idaho 83642
Meridian, Idaho 83642
Velocity Clinical Research, Sioux City
Sioux City, Iowa 51106
Sioux City, Iowa 51106
Velocity Clinical Research, Covington
Covington, Louisiana 70433
Covington, Louisiana 70433
Velocity Clinical Research, Lafayette
Lafayette, Louisiana 70508
Lafayette, Louisiana 70508
Velocity Clinical Research, New Orleans
New Orleans, Louisiana 70119
New Orleans, Louisiana 70119
Advanced Primary and Geriatric Care/Avacare
Rockville, Maryland 20850
Rockville, Maryland 20850
Velocity Clinical Research, Rockville
Rockville, Maryland 20854
Rockville, Maryland 20854
DM Clinical Research
Southfield, Michigan 48076
Southfield, Michigan 48076
Velocity Clinical Research - Norfolk
Norfolk, Nebraska 68701
Norfolk, Nebraska 68701
Quality Clinical Research, Inc
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Velocity Clinical Research, Omaha
Omaha, Nebraska 68134
Omaha, Nebraska 68134
DM Clinical Research
Jersey City, New Jersey 07306
Jersey City, New Jersey 07306
Velocity Clinical Research, Binghamton
Binghamton, New York 13905
Binghamton, New York 13905
Rochester Clinical Research
Rochester, New York 14609
Rochester, New York 14609
Trial Management Associates, LLC
Wilmington, North Carolina 28403
Wilmington, North Carolina 28403
Velocity Clinical Research, Cleveland
Beachwood, Ohio 44122
Beachwood, Ohio 44122
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Velocity Clinical Research, Springdale
Cincinnati, Ohio 45246
Cincinnati, Ohio 45246
Tekton Research, LLC
Yukon, Oklahoma 73099
Yukon, Oklahoma 73099
DM Clinical Research
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Velocity Clinical Research, Anderson
Anderson, South Carolina 29621
Anderson, South Carolina 29621
Velocity Clinical Research Gaffney
Gaffney, South Carolina 29340
Gaffney, South Carolina 29340
Tekton Research, LLC
Austin, Texas 78745
Austin, Texas 78745
Velocity Clinical Research, Austin
Austin, Texas 78759
Austin, Texas 78759
Pan American Clinical Research, LLC
Brownsville, Texas 78520
Brownsville, Texas 78520
DM Clinical Research
Houston, Texas 77065
Houston, Texas 77065
DM Clinical Research
Houston, Texas 77081
Houston, Texas 77081
Tekton Research, LLC
San Antonio, Texas 78229
San Antonio, Texas 78229
Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088
West Jordan, Utah 84088
Clinical Research Partners LLC
Richmond, Virginia 23226
Richmond, Virginia 23226
Velocity Clinical Research, Suffolk
Suffolk, Virginia 23435
Suffolk, Virginia 23435
More Details
- NCT ID
- NCT06742281
- Status
- Recruiting
- Sponsor
- CyanVac LLC
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 10,000 participants, plus an additional 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.