Status:
RECRUITING
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
Centers for Disease Control and Prevention
U.S. Food and Drug Administration (FDA)
Conditions:
COVID -19
COVID - 19
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief Summary
CIRV2 is a Phase IV randomized, open-label, trial of FDA-approved COVID-19 and/or influenza vaccines (no more than minimal risk) with longitudinal follow-up. In 2025 CIRV2 will compare immunogenicity ...
Detailed Description
The goal of the Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) study is to conduct, on a yearly basis, direct comparisons of immunogenicity and reactogenicity of the most recent vers...
Eligibility Criteria
Inclusion Criteria
-
18-79 years old
-
Have a history of any of the following risk factors for severe COVID:
- Asthma
- Physical inactivity (defined as <150 mins of moderate activity per week or <75 mins of vigorous activity per week)
- HIV with CD4 count ≥ 500 cells/ul
- Current or prior smoker
- Depression or other mood disorder
- Schizophrenia spectrum disorder
- Cerebrovascular disease
- Heart failure
- Coronary artery disease
- Cardiomyopathy
- Pulmonary embolism
- Pulmonary hypertension
- Cystic fibrosis
- Bronchiectasis
- Chronic obstructive pulmonary disease
- Interstitial Lung Disease
- Stage I or II chronic kidney disease
- Stage 1 defined as normal GFR (> 90) but with other signs of kidney damage such as proteinuria or hematuria
- Stage 2 defined as having a glomerular filtration rate (GFR) of 60 - 89 ml/min/1.73m2
- Gestational diabetes
- Type 1 diabetes with most recent HgbA1C < 7.5%
- Type 2 diabetes with most recent HgbA1C < 7.5%
- Obesity with BMI ≥ 30 and < 40
- Liver disease without cirrhosis and with liver enzyme levels
- (AST and ALT) no greater than three times the upper limit of normal
-
Military Health System beneficiary and DEERS eligible
-
Willing to be randomized to receive either the Novavax COVID-19 vaccine or the mRNA Pfizer-BioNTech COVID-19 vaccine
-
Will be able to return for a clinic visit in approximately 30 days and be able to follow-up online for the next 9 months.
Exclusion Criteria
-
History of severe allergy or severe adverse reaction such as myocardial inflammation to any component of the mRNA COVID-19 vaccines or the Novavax recombinant COVID-19 vaccine
-
Received a COVID-19 vaccine in the last 3 months.
-
Tested positive for COVID-19 in the past 3 months.
- Presence of fever, cough, chills, shortness of breath, runny nose, or sore throat today on day of screening/enrollment visit.
-
Active use of immune modulating medications.
- Defined as active use of chronic immune modulating medications such as systemic corticosteroids at a dose equivalence of 20 mg prednisone or greater daily for over one month, chemotherapy, cytokine inhibitors, or agents that reduce T cell or B cell numbers or function.
-
Diagnosed with immunocompromised stated.
- Defined as: presence of a disease that is actively causing severe immune suppression or history of prior splenectomy (removal of spleen).
-
Diabetes with the most recent HgbA1C ≥ 7.5.
-
Stage III or greater chronic kidney disease
- Defined as estimated glomerular filtration rate < 60 ml/min/1.73m2)
-
Obesity with a BMI ≥ 40
-
HIV with a CD4 cell count < 500 cells/ul
-
History of solid organ or bone marrow transplant.
-
Active malignancy
- Defined as any cancer that is currently being treated or has shown evidence of progression within the past year.
-
Chronic liver disease with compensated or decompensated cirrhosis, or liver enzyme levels (AST or ALT) greater than three times the upper limit of normal.
Key Trial Info
Start Date :
November 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT07287137
Start Date
November 12 2025
End Date
September 1 2027
Last Update
December 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814