A Two-Stage Sequential Phase 2b Trial Design for Evaluating Vaccine Efficacy and Immune Correlates for Multiple HIV Vaccine Regimens
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*Peter Brian Gilbert, U Washington and FHCRC 

Keywords: Adaptive design, immune correlates of protection, principal stratification, vaccine efficacy trial

This talk will summarize a trial design (Gilbert et al., 2011, SCID) for evaluating multiple prime-boost HIV vaccine regimens against a shared placebo group, with main objectives 1) to evaluate VE of each regimen against HIV exposures occurring near the immunizations; 2) to evaluate durability of VE for each vaccine regimen showing evidence for positive VE; 3) to expeditiously evaluate the immune correlates of protection if any vaccine regimen shows evidence for positive VE; and (4) to compare VE among the vaccine regimens. Testing multiple vaccine regimens is important for providing a well-powered assessment of correlates of infection risk and of correlates/surrogates of protection. The talk will address statistical methods for assessing immune correlates/surrogates of protection, as well as the use of Bayesian statistics for enhancing the analysis (Gilbert, Berger et al., 2011, JID).