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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study

IDCRP-154: Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study

Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study (NCT07287137) is a Phase 4 interventional studying COVID -19 and COVID - 19, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 54 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused COVID -19 subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

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. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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. 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.

Treatments Being Tested

DRUG

Pfizer-BioNTech mRNA COVID-19 vaccine

COVID-19 Vaccine, mRNA

DRUG

Novavax recombinant protein vaccine

Recombinant protein vaccine

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Walter Reed National Military Medical Center
Bethesda, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07287137), the sponsor (Henry M. Jackson Foundation for the Advancement of Military Medicine), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07287137 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07287137?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07287137?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07287137. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07287137. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.