Issues in the Design of HIV Vaccine Efficacy Trials
Steven G. Self
from: AIDS Vaccine Development: Challenges and Opportunities (Edited by: Wayne Koff, Patricia Kahn and Ian D. Gust). Caister Academic Press, U.K. (2007)
Abstract
This chapter discusses several issues in the design of HIV vaccine efficacy trials. It first describes how primary objectives are formulated for Phase IIB and Phase III studies and how they are used to determine the numbers of volunteers needed for these designs. The discussion then turns to primary efficacy endpoints, and to why and how they differ from those typically used in efficacy trials for other vaccines. Two possible designs for "nested" studies to examine immunologic correlates of protection against HIV/AIDS are described, along with some potential pitfalls in interpreting them. The chapter concludes with some guidelines for planning analyses of subgroups within trial cohorts and for determining the proportion of volunteers to allocate to vaccine versus placebo groups read more ...
