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Activity Number: 428
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract #315122
Title: Estimation to Assess Surrogate Marker in Vaccine Trials
Author(s): SoYoung Kim* and Ying Huang
Companies: Fred Hutchinson Cancer Research Center and Fred Hutchinson Cancer Research Center
Keywords: AIDS ; Causal inference ; Clinical trial ; Missing data ; Potential outcomes ; Surrogate marker

In HIV vaccine/prevention clinical trials, evaluating vaccine efficacy is generally expensive due to the long trial period to observe clinical outcomes. Thus, it is of interest to find vaccine-induced immune responses as surrogate markers for the true study endpoint, which can be used to select vaccine regimens based on their immunogenicity in phase I/II studies for entering the future efficacy trials. We adopt a potential outcomes framework to evaluate vaccine-induced immune responses as principal surrogate endpoints for vaccine's effect in preventing HIV infection. However, addressing this problem is difficult because immune response to the vaccine is only observed in the vaccine group. Previously, Follmann (2006) proposed baseline irrelevant predictor (BIP) and closeout placebo vaccination for a binary outcome and Qin et al.(2008) extended this approach to discrete survival outcome. However, there have not been any studies on the asymptotic properties of the estimated likelihood estimator in this particular setting. In this paper, I developed asymptotic properties for surrogate endpoint assessment in vaccine trials with a binary outcome as well as time-to-event clinical endpoint

Authors who are presenting talks have a * after their name.

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