Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
NCT ID: NCT07287137
Last Updated: 2025-12-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
54 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-11-12
Study Completion Date
2027-09-30
Brief Summary
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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 and reactogenicity of the recombinant Novavax COVID-19 vaccine and the mRNA Pfizer-BioNTech COVID-19 vaccine.
Detailed Description
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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 versions of FDA-approved vaccines for COVID-19 and/or influenza. Studies will be conducted on individuals that are FDA eligible to receive these vaccines and do not have a medical condition that severely impairs their immune system. For 2025, the study will directly compare the immunogenicity and reactogenicity of the 2025 Novavax recombinant COVID-19 vaccine with the 2025 Pfizer/BioNTech mRNA COVID-19 vaccine.
Conditions
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COVID -19
COVID - 19
COVID 19
Influenza
Respiratory Virus
Respiratory Viruses
Respiratory Virus Infection
Respiratory Virus Infections
Keywords
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COVID-19 vaccine
Influenza vaccine
Respiratory virus vaccine
Immunogenicity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Enrollment of 50-54 individuals to receive the vaccine (up to 27 per arm) per year.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Open-label, with concealment of vaccine allocation until time of vaccination and blinding of all laboratory personnel conducting antibody assays.
Study Groups
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For fall of 2025, Arm 1 of the study will be the Pfizer-BioNTech mRNA COVID-19 vac
Arm 1 of the study will be Pfizer-BioNTech mRNA COVID-19 vaccine
Group Type
ACTIVE_COMPARATOR
Pfizer-BioNTech mRNA COVID-19 vaccine
Intervention Type
DRUG
COVID-19 Vaccine, mRNA
For fall of 2025, Arm 2 of the study will be the Novavax recombinant protein vaccine
Arm 2 of the study will be the Novavax recombinant protein vaccine
Group Type
ACTIVE_COMPARATOR
Novavax recombinant protein vaccine
Intervention Type
DRUG
Recombinant protein vaccine
Interventions
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Pfizer-BioNTech mRNA COVID-19 vaccine
COVID-19 Vaccine, mRNA
Intervention Type
DRUG
Novavax recombinant protein vaccine
Recombinant protein vaccine
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. 18-79 years old
2. 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
3. Military Health System beneficiary and DEERS eligible
4. Willing to be randomized to receive either the Novavax COVID-19 vaccine or the mRNA Pfizer-BioNTech COVID-19 vaccine
5. 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.
2. 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
3. Military Health System beneficiary and DEERS eligible
4. Willing to be randomized to receive either the Novavax COVID-19 vaccine or the mRNA Pfizer-BioNTech COVID-19 vaccine
5. 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
1. 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
2. Received a COVID-19 vaccine in the last 3 months.
3. 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.
4. 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.
5. 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).
6. Diabetes with the most recent HgbA1C ≥ 7.5.
7. Stage III or greater chronic kidney disease
\- Defined as estimated glomerular filtration rate \< 60 ml/min/1.73m2)
8. Obesity with a BMI ≥ 40
9. HIV with a CD4 cell count \< 500 cells/ul
10. History of solid organ or bone marrow transplant.
11. Active malignancy
\- Defined as any cancer that is currently being treated or has shown evidence of progression within the past year.
12. Chronic liver disease with compensated or decompensated cirrhosis, or liver enzyme levels (AST or ALT) greater than three times the upper limit of normal.
2. Received a COVID-19 vaccine in the last 3 months.
3. 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.
4. 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.
5. 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).
6. Diabetes with the most recent HgbA1C ≥ 7.5.
7. Stage III or greater chronic kidney disease
\- Defined as estimated glomerular filtration rate \< 60 ml/min/1.73m2)
8. Obesity with a BMI ≥ 40
9. HIV with a CD4 cell count \< 500 cells/ul
10. History of solid organ or bone marrow transplant.
11. Active malignancy
\- Defined as any cancer that is currently being treated or has shown evidence of progression within the past year.
12. Chronic liver disease with compensated or decompensated cirrhosis, or liver enzyme levels (AST or ALT) greater than three times the upper limit of normal.
Minimum Eligible Age
18 Years
Maximum Eligible Age
79 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Centers for Disease Control and Prevention
FED
Sponsor Role
collaborator
U.S. Food and Drug Administration (FDA)
UNKNOWN
Sponsor Role
collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Edward Mitre, MD
Role: PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences
Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Irma Barahona
Role: primary
References
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Other Identifiers
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IDCRP-154
Identifier Type: -
Identifier Source: org_study_id