NCT07287137 Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
| NCT ID | NCT07287137 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine |
| Condition | COVID -19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 54 participants in total. It began in 2025-11-12 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 2026 CIRV2 will compare immunogenicity and reactogenicity of the recombinant Novavax COVID-19 vaccine and the mRNA Pfizer-BioNTech COVID-19 vaccine.
Eligibility Criteria
Inclusion Criteria 1. 18-79 years old 2. Have a history of any of the following risk factors for severe COVID: Current: * Age \> 65 years old * 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 * Smoker * Obesity with BMI ≥ 30 and \< 40 History of: * Asthma * 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% * Liver disease without cirrhosis and with liver enzyme levels (AST and ALT) no greater than three times the upper limit of normal * Smoking 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, Day 150, 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.
Contact & Investigator
Edward Mitre, MD
PRINCIPAL INVESTIGATOR
Uniformed Services University of the Health Sciences
Frequently Asked Questions
Who can join the NCT07287137 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying COVID -19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07287137 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07287137 currently recruiting?
Yes, NCT07287137 is actively recruiting participants. Contact the research team at mspevak@hjf.org for enrollment information.
Where is the NCT07287137 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT07287137 clinical trial?
NCT07287137 is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. The principal investigator is Edward Mitre, MD at Uniformed Services University of the Health Sciences. The trial plans to enroll 54 participants.
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