NCT07287137

Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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 and reactogenicity of the recombinant Novavax COVID-19 vaccine and the mRNA Pfizer-BioNTech COVID-19 vaccine.

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 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

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

Interventions

Type	Name	Description
DRUG	Pfizer-BioNTech mRNA COVID-19 vaccine	COVID-19 Vaccine, mRNA
DRUG	Novavax recombinant protein vaccine	Recombinant protein vaccine

Timeline

• Start date: 2025-11-12
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study