Abstract While the HVTN 505 trial showed no overall efficacy of the tested vaccine to prevent HIV infection over placebo, markers measuring immune response to vaccination were strongly correlated with infection. This finding generated the hypothesis that some marker-defined vaccinated subgroups...

Abstract We develop a transport formula for predicting overall cumulative vaccine efficacy through time t ( $$VE(t)$$ ) to prevent clinically significant infection with a genetically diverse pathogen (e. g., HIV infection) in a new setting for which a Phase III preventive vaccine efficacy...

Abstract A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct inferences on clinical treatment...

type="main" xml:id="rssc12067-abs-0001" <title type="main">Summary</title> <p>The paper develops hypothesis testing procedures for the stratified mark-specific proportional hazards model in the presence of missing marks. The motivating application is preventive human immunodeficiency virus (HIV) vaccine efficacy trials,...</p>

Assessing per-protocol (PP) treatment efficacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol...

It is frequently of interest to estimate the intervention effect that adjusts for post-randomization variables in clinical trials. In the recently completed HPTN 035 trial, there is differential condom use between the three microbicide gel arms and the no-gel control arm, so intention-to-treat...