Statistical challenges in developing immune correlates to support licensure of Ebola vaccines
*Ivan S.F. Chan, Merck Research Laboratories  Kenneth Liu, Merck Research Laboratories 

Keywords: Ebloa, immune correlates of protection, vaccine, challenge study

Given the current, unprecedented Ebola epidemic in West Africa that has caused more than 26,900 reported cases with over 11,100 deaths [WHO Situation Report, 5/20/2015], 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.