Adaptive Designs for Vaccine Clinical Trials

• Activity Number: 36
• Type: Contributed
• Date/Time: Sunday, July 29, 2012 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Ghideon Ghebregiorgis*+
• Companies: FDA
• Keywords: Adaptive Design ; Vaccine clinical trials ; Immune response ; HIV vaccine efficacy

Abstract

Despite the increase of our understanding of host immune responses, the sequencing of pathogen genomes, and other technological advances, important hurdles remain for developing vaccines for a variety of diseases. Developing a vaccine against diseases like the human immunodeficiency virus (HIV), tuberculosis (TB), Malaria etc poses a challenge in vaccine clinical trial studies. Adaptive clinical trial designs allow a trial to be modified in response to data acquired during the study. Such trials would rapidly screen out poor vaccine candidates, enable extended evaluation of promising candidates and provide key information on the immunological basis. This talk will provide various perspectives in utilizing adaptive trial design methods for use in vaccine clinical trials; discuss adaptive designs from regulatory prospective including the recommendations from the FDA guidance. Strength and Weakness of the approach will be discussed through examples of adaptive designs used in vaccine clinical trials.