Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria 1. 18-79 years old 2. Have a history of any of the following risk factors for severe COVID: * 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