4 papers
Improving the efficiency of infectious disease prevention trials using negative control outcome event times
Ethan Ashby, Zhewei Zhang, Tanya P. Garcia +3
Baseline covariate adjustment can enhance the efficiency of randomized trials by improving precision of treatment effect estimates. However, the precision gain depends on how stron…
Efficient estimation of cumulative incidence curves via data fusion with surrogates: application to integrated analysis of vaccine trial and immunobridging data
Pan Zhao, Peter B. Gilbert, Oliver Dukes +1
Refined vaccine regimens containing variant-matched inserts are often authorized based on historical phase 3 efficacy trials together with immunobridging studies. Phase 3 trials ar…
Dealing with positivity violations in mediation analysis via weighted controlled effects, with application to assessing immune correlates of protection in antigen-experienced participants
Qijia He, Bo Zhang
Causal mediation analysis has become an important and increasingly used framework for evaluating candidate immune response biomarkers in vaccine research. A controlled effects appr…
Debiasing hazard-based, time-varying vaccine effects using vaccine-irrelevant infections: An observational extension of a pivotal Phase 3 COVID-19 vaccine efficacy trial
Ethan Ashby, Dean Follmann, Holly Janes +5
Understanding how vaccine effectiveness (VE) changes over time can provide evidence-based guidance for public health decision making. While commonly reported by practitioners, time…