Biostatistics Weekly Seminar

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

Speaker Itinerary

Topic revision: r2 - 31 Oct 2023, CierraStreeter

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