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

NCT07287137 Phase 4 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Henry M. Jackson Foundation for the Advancement of Military Medicine
Phase	Phase 4
Status	ACTIVE_NOT_RECRUITING
Enrolment	54
Start date	2025-11-12
Completion	2027-09

Conditions

• COVID -19
• COVID - 19
• COVID 19
• Influenza
• Respiratory Virus
• Respiratory Viruses
• Respiratory Virus Infection
• Respiratory Virus Infections

Interventions

• Pfizer-BioNTech mRNA COVID-19 vaccine
• Novavax recombinant protein vaccine

Primary outcomes

• Variant-specific immune responses — IgG binding antibody levels and neutralizing antibody titers will be assessed on serum samples obtained just prior to vaccination and 30 days (+/- 10 days) after vaccination.
  The primary endpoint is variant-specific immune response (magnitude and breadth) to licensed recombinant and mRNA COVID-19 products administered to healthy adult MHS beneficiaries. This will include quantifying the magnitude of binding and neutralizing antibodies to the vaccine variants and to the dominant variant present one month post-vaccination. Specifically, we will test neutralizing titers (defined as the inverse serum dilution causing a 50% reduction in relative light units in a pseudovirus neutralization assay) and IgG binding antibody levels (measured in arbitrary units) against the following SARS-CoV-2 variants: NB.1.8.1 and XFG (predominant circulating strains in fall 2025), JN.1 and LP.8.1 (vaccine strains), and Wuhan-1 (ancestral strain).

Countries

United States