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CIRV2 Study: Comparing COVID-19 Vaccines

The CIRV2 study is comparing two FDA-approved COVID-19 vaccines: the Pfizer-BioNTech mRNA COVID-19 vaccine and the Novavax recombinant protein vaccine. This study aims to see how well each vaccine helps your body create an immune response (immunogenicity) and what side effects you might experience (reactogenicity). Researchers will measure your immune response by looking at antibody levels in your blood before vaccination and about 30 days after. You may be able to join if you are between 18 and 79 years old and have certain risk factors for severe COVID-19, such as asthma or being a current or prior smoker. The study plans to enroll 54 participants, but its current status is unclear.

Study design
This is an open-label, randomized study, meaning you and the researchers will know which vaccine you receive. It plans to enroll 54 participants.
What's involved
You would provide blood samples just before vaccination and again about 30 days after vaccination.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be measured about 30 days after vaccination.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07287137

Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study

Active, Not Recruiting
PHASE4Ages 18–79InterventionalPrevention
Henry M. Jackson Foundation for the Advancement of Military Medicine
~54 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Pfizer-BioNTech mRNA COVID-19 vaccineNovavax recombinant protein vaccine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Variant-specific immune responses
Measured over 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.

Conditions

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

Explore related trials

COVID-19 InfectionInfluenzaCD4 Gene

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Edward Mitre, MD · PRINCIPAL_INVESTIGATOR · Uniformed Services University of the Health Sciences

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Variant-specific immune responsesIgG 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).