Predicting Vaccine Efficacy Based on Associations Among Disease, Immune Responses, and Treatment

• Activity Number: 487
• Type: Contributed
• Date/Time: Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Lihan Yan*+
• Companies: FDA
• Keywords: Vaccine Efficacy ; Correlate of Protection

Abstract

In vaccine clinical trials, vaccine efficacy and immunogenicity are two of the most important components in the evaluation of the success of the vaccine. Establishing correlate of protection to bridge between the immunogenicity responses and vaccine efficacy is one of the challenging tasks for many researchers. Because of the complication in human biology mechanisms, the predictability of protection based on immunogenicity measures varies with different levels of associations among disease, immune response and treatment. Specialized log-linear models are designed to study the associations. This presentation shows simulation results from the designed models to explore the prediction of vaccine efficacy with various levels of correlation among disease status, immune response and treatment group.