Vaccines are typically developed for disease prevention in healthy
subjects. The unique characteristics of vaccine development pose special
challenges in designing vaccine efficacy trials. In addition, immune
responses are measured to identify potential markers that correlate with
efficacy. In this talk, we will discuss the statistical issues involved in
design and analysis of vaccine efficacy trials and in assessing correlates
of protection. We will illustrate some potential difficulties in applying
classical methods (such as Prentice's criteria) for validating surrogate
endpoints. Then, we will present some approaches in evaluating correlates
of protection, including the concept of protective level and the use of
statistical models to examine the relationship between efficacy and the
whole distribution of immune responses. Real vaccine examples will be
used to illustrate the methods.
Meet the speaker in Room 212 Cockins Hall at 4:30 p.m. Refreshments will be served.