Crossover and Individual Step-Wedge Study Designs to Estimate Vaccine Efficacy and Durability
Dean Follmann Assistant Director for Biostatistics National Institutes of Allergy and Infectious Diseases
COVID-19 vaccines demonstrated high initial efficacy which resulted in the placebo group being crossed over to receive the efficacious vaccine. While the loss of a placebo group might seem to end the trial, we demonstrate how post-crossover data can be used to estimate durability of the effect of vaccination, even for variants that emerge post-crossover. We additionally show how the benefit of a booster dose can be estimated when individuals gradually get boosted by dynamically comparing the unboosted to the boosted cohort in an individual step-wedge analysis. These designs will be illustrated using data from the Novavax and Moderna phase III vaccine trials.
Virtual: Zoom Link to Follow 08 November 2023 1:30pm