Trial Design, Participants, Procedures, and Oversight
NVX-CoV2373.Healthy, HIV infection, diabetes
INFECTIOUS DISEASES, ALLERGY, CARDIOVASCULAR DISEASE, HIV INFECTION, DIABETES
PREVENT-19 is a phase 3, randomized, observer-blinded, placebo-controlled clinical trial initially conducted in adults in the US and Mexico evaluating the safety, immunogenicity, and efficacy of NVX-CoV2373.Healthy adolescents aged 12 through 17 years or those with stable chronic medical conditions (as determined by the investigator based on review of overall health status, vital signs, medical history, and physical examination results), including chronic pulmonary, kidney, or cardiovascular disease; type 1 or 2 diabetes; or well-controlled HIV infection (defined as undetectable HIV RNA [<50 copies/mL] and CD4 count >200/μL for at least 1 year [to convert CD4 count to ×10Participants were allocated without age stratification in a 2:1 ratio to receive two 0.5-mL intramuscular injections of either NVX-CoV2373 (5 μg recombinant SARS-CoV-2 S plus 50 μg Matrix-M adjuvant) or normal saline placebo 21 days apart. Randomization used a web-based interactive system. Site personnel who managed study vaccine logistics and preparation had no subsequent role in participant assessment.Trial data were available to all authors, who vouched for its accuracy and completeness and for fidelity to the trial protocol. The trial is ongoing, and investigators, Novavax, the clinical team, and the participants remain blinded to participant-level initial treatment assignments. Safety and efficacy were monitored through the placebo-controlled portion of the trial with regular reviews of unblinded data by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health– sponsored data and safety monitoring board (