Pfizer-BioNTech vs Novavax Vaccines for COVID-19

(CIRV2 Trial)

Overseen By Marianne Spevak, BSHS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Edward Mitre, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

This trial is for healthy volunteers interested in helping compare the immune responses to two FDA-approved COVID-19 vaccines: Novavax's recombinant protein vaccine and Pfizer-BioNTech's mRNA vaccine. Specific eligibility criteria are not provided, but typically participants should meet certain health standards.

Inclusion Criteria

I am between 18 and 79 years old.

I have risk factors for severe COVID and can follow the study requirements.

Exclusion Criteria

History of severe allergy or severe adverse reaction to any component of the mRNA COVID-19 vaccines or the Novavax recombinant COVID-19 vaccine, received a COVID-19 vaccine in the last 3 months, tested positive for COVID-19 in the past 3 months with presence of specific symptoms, active use of immune modulating medications, diagnosed with immunocompromised state, diabetes with the most recent HgbA1C ≥ 7.5, stage III or greater chronic kidney disease, obesity with a BMI ≥ 40, HIV with a CD4 cell count < 500 cells/ul, history of solid organ or bone marrow transplant, active malignancy, chronic liver disease with compensated or decompensated cirrhosis, or liver enzyme levels (AST or ALT) greater than three times the upper limit of normal.

What Are the Treatments Tested in This Trial?

Interventions

• Novavax COVID-19 Vaccine
• Pfizer-BioNTech COVID-19 Vaccine

Trial Overview

The CIRV2 study is testing how well people's bodies respond to either the Novavax or Pfizer-BioNTech COVID-19 vaccines over time. It's a Phase IV trial where participants will be randomly assigned to receive one of these approved vaccines.

How Is the Trial Designed?

Group I: For fall of 2025, Arm 1 of the study will be the Pfizer-BioNTech mRNA COVID-19 vac Active Control 1 Intervention

Arm 1 of the study will be Pfizer-BioNTech mRNA COVID-19 vaccine

Group II: For fall of 2025, Arm 2 of the study will be the Novavax recombinant protein vaccine Active Control 1 Intervention

Arm 2 of the study will be the Novavax recombinant protein vaccine

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

U.S. Food and Drug Administration (FDA)

Collaborator

Trials

2

Recruited

470+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+