A Two-Stage Sequential Phase 2b Trial Design for Evaluating Vaccine Efficacy and Immune Correlates for Multiple HIV Vaccine Regimens
View Presentation *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).
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC