118 – Statistical Challenges in Clinical Trials of Novel Vaccines
Immune Correlates of Protection: Recent Developments and Future Challenges
Andrew Dunning
Sanofi Pasteur
Immune correlates of protection are immunological assays which have been shown to be associated with protection from disease, and more particularly threshold values of assays which differentiate individuals susceptible to disease from those protected. They are of considerable interest in vaccine research. Important advances in statistical methods have been made in the last 10 years: a framework for evaluating candidate assays has been postulated, causal inference methods proposed and implemented, consistent terminology suggested and methods for finding thresholds and quantifying protection investigated. Some earlier methods have been further developed. The presentation will attempt to summarize the work done, introduce some new work, and frame the questions which might need to be addressed for an immune correlate of protection to serve in a regulatory context as a surrogate endpoint for clinical disease in a vaccine efficacy trial.