IDCRP-154: Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
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.
• 18-79 years old
• 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%
⁃ Liver disease without cirrhosis and with liver enzyme levels (AST and ALT) no greater than three times the upper limit of normal
⁃ Smoking
• Military Health System beneficiary and DEERS eligible
• Willing to be randomized to receive either the Novavax COVID-19 vaccine or the mRNA Pfizer-BioNTech COVID-19 vaccine
• 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.