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Activity Number: 462
Type: Invited
Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
Sponsor: ASA
Abstract #317961 View Presentation
Title: Statistical Challenges in Developing Immune Correlates to Support Licensure of Ebola Vaccines
Author(s): Ivan S.F. Chan* and Kenneth Liu and Sheri A. Dubey and John Konz
Companies: Merck Research Laboratories and Merck Research Laboratories and Merck Research Laboratories and Merck Research Laboratories
Keywords:
Abstract:

Given the current, unprecedented Ebola epidemic in West Africa that has caused more than 26,000 reported cases with over 10,800 deaths [WHO Situation Report, 4/26/2015], a high priority has been placed on development of prophylactic vaccines. International partnerships among Governments, WHO, and Industry have enabled rapid clinical development of an rVSV Ebola vaccine with multiple phase I to phase III studies being conducted simultaneously to support licensure. An 'accelerated approval' pathway based on immunogenicity data is also being considered in case the ongoing efficacy trials become inconclusive due to the declining incidence of Ebola. Therefore, it is important to identify immune correlates that can be used to support the basis of licensure. In this talk, we will discuss some key statistical challenges in developing immune correlates for Ebola vaccine, including endpoint selection, success criteria, and the use of animal (e.g., non-human primate) challenge model. Examples and simulations will be used to illustrate the proposed methods.


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

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