Assessing Immune Markers and Correlates of Protection in Vaccine Studies
*Ivan S. F. Chan, Merck Research Laboratories Keywords: Vaccines, correlate of protection, immune markers, efficacy In vaccine clinical trials, immune responses are often used to measure the effect of a vaccine because they correlate with a vaccine’s protective efficacy against the target disease. In this talk, we will discuss the statistical issues involved in assessing immune markers and correlates of protection in vaccine clinical trials and illustrate some potential difficulties in applying classical methods (such as Prentice’s criteria) for validating surrogate endpoints. We will present approaches in evaluating correlates of protection, including the concept of protective level and the use of statistical models to examine the relationship between long-term disease protection and the whole distribution of immune responses. We will use a varicella (chickenpox) vaccine example to illustrate the methods.
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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