This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 395
Type: Topic Contributed
Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306850
Title: Evaluating Correlates of Protection in Vaccine Studies
Author(s): Ivan S.F. Chan*+
Companies: Merck Research Laboratories
Address: 351 North Sumneytown Pike, North Wales, PA, 19454,
Keywords: immune responses ; efficacy ; correlates of protection ; vaccines ; Prentice criteria
Abstract:

In vaccine studies, immune responses are often measured to identify potential markers that correlate with efficacy. Once identified, prediction of efficacy can then be based on these correlates of protection. In this talk, we will discuss the statistical issues and challenges involved in evaluating correlates of protection and their predictive value. We will discuss the key statistical properties of commonly used approaches such as the individual, population, titer-specific method, statistical modeling, and the Prentice's criteria. Considerations for study designs will also be given. Real examples will be used to illustrate the methods.


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