ACTIVE_NOT_RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-05

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06742281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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. * 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).

Inclusion Criteria

Exclusion 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.
* 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.

* 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.
* 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).

Contacts and Locations

Principal Investigator

Hong Jin

PRINCIPAL_INVESTIGATOR

CyanVac LLC

Study Locations (Sites)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207

United States

Velocity Clinical Research, Phoenix

Phoenix, Arizona, 85006

United States

Velocity Clinical Research, Chula Vista

Chula Vista, California, 91911

United States

Velocity Clinical Research, San Diego

La Mesa, California, 91942

United States

Imax Clinical Trials

La Palma, California, 90623

United States

Artemis Institute for Clinical Research

Riverside, California, 92503

United States

Clinical Innovations Inc. dba CITrials

Riverside, California, 92506

United States

Avacare

Sacramento, California, 95864

United States

Collaborative Neuroscience Research, LLC

Torrance, California, 90504

United States

Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia, 20016

United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009

United States

Homestead Associates in Research, Inc

Homestead, Florida, 33033

United States

Biscayne Clinical Research

North Miami Beach, Florida, 33169

United States

Headlands Research Orlando

Orlando, Florida, 32819

United States

Best Choice Medical and Research Service

Pembroke Pines, Florida, 33024

United States

Forcare Clinical Research

Tampa, Florida, 33613

United States

Guardian Angel Research Center

Tampa, Florida, 33614

United States

Lifeline Primary Care/Avacare

Lilburn, Georgia, 30047

United States

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406

United States

Clinical Research Atlanta

Stockbridge, Georgia, 30281

United States

Velocity Clinical Research, Boise

Meridian, Idaho, 83642

United States

Velocity Clinical Research, Sioux City

Sioux City, Iowa, 51106

United States

Velocity Clinical Research, Covington

Covington, Louisiana, 70433

United States

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, 70508

United States

Velocity Clinical Research, New Orleans

New Orleans, Louisiana, 70119

United States

CBH Health

Gaithersburg, Maryland, 20877

United States

Advanced Primary and Geriatric Care/Avacare

Rockville, Maryland, 20850

United States

Velocity Clinical Research, Rockville

Rockville, Maryland, 20854

United States

DM Clinical Research

Southfield, Michigan, 48076

United States

Velocity Clinical Research - Norfolk

Norfolk, Nebraska, 68701

United States

Quality Clinical Research, Inc

Omaha, Nebraska, 68114

United States

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134

United States

DM Clinical Research

Jersey City, New Jersey, 07306

United States

Velocity Clinical Research, Binghamton

Binghamton, New York, 13905

United States

Rochester Clinical Research

Rochester, New York, 14609

United States

Trial Management Associates, LLC

Wilmington, North Carolina, 28403

United States

Velocity Clinical Research, Cleveland

Beachwood, Ohio, 44122

United States

Velocity Clinical Research, Mt. Auburn

Cincinnati, Ohio, 45219

United States

Velocity Clinical Research, Springdale

Cincinnati, Ohio, 45246

United States

Tekton Research, LLC

Yukon, Oklahoma, 73099

United States

DM Clinical Research

Philadelphia, Pennsylvania, 19107

United States

Velocity Clinical Research, Anderson

Anderson, South Carolina, 29621

United States

Velocity Clinical Research Gaffney

Gaffney, South Carolina, 29340

United States

Avacare

Austin, Texas, 78705

United States

Tekton Research, LLC

Austin, Texas, 78745

United States

Velocity Clinical Research, Austin

Austin, Texas, 78759

United States

Pan American Clinical Research, LLC

Brownsville, Texas, 78520

United States

Avacare

Fort Worth, Texas, 76135

United States

DM Clinical Research

Houston, Texas, 77065

United States

DM Clinical Research

Houston, Texas, 77081

United States

Avacare

San Angelo, Texas, 76904

United States

Tekton Research, LLC

San Antonio, Texas, 78229

United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088

United States

Clinical Research Partners LLC

Richmond, Virginia, 23226

United States

Velocity Clinical Research, Suffolk

Suffolk, Virginia, 23435

United States

Collaborators and Investigators

Sponsor: CyanVac LLC

Hong Jin, PRINCIPAL_INVESTIGATOR, CyanVac LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-05

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-12-05

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

COVID-19 intranasal vaccine

Additional Relevant MeSH Terms

COVID-19