Challenges in Evaluation of Correlates of Protection and Immunobridging in Vaccine Trials

• Activity Number: 624
• Type: Invited
• Date/Time: Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Peter Gilbert*+ and Ivan S. F. Chan*+ and Ghideon Ghebregiorgis*+ and Catherine Njue*+
• Companies: University of Washington and Fred Hutchinson Cancer Research Center and Merck Research Laboratories and CBER/FDA and Health Canada
• Keywords: Vaccines ; Correlate of protection ; Biomarker ; Bridging trials

Abstract

One of important goals of vaccine development is to identify potential immunological markers that predict vaccine efficacy. Having such a predictive marker can substantially accelerate the vaccine development as subsequent studies can be conducted efficiently based on these immunological markers instead of efficacy endpoints. There have been some recent statistical development in evaluation of correlates of protection and new vaccines approved based on immunobridging. In this panel session, we will discuss the methods of evaluating correlates and the related issues for designing immunobridging trials (e.g, endpoint selection, relevance, success criteria). Experts from academia, industry, and regulatory areas will share their perspectives and make recommendations on these issues.