Development of novel vaccines evolves from identification of an appropriate antigen, formulation and vaccine regimen to assessment of safety, immune response and efficacy in animal models which are intended to be informative and predictive of human responses. In addition to selecting and developing relevant animal models, successful bridging of animal and human studies requires development and validation of “species-neutral” methods for measuring potential immune correlates in both species. A case study looking at Ebola vaccine models and immune responses will be presented in which two assays were validated and implemented to bridge vaccine responses.
Describe key aspects for bridging between animal models and humans
Summarize ways to align bioanalytical methods across species
Define what is meant by a species neutral method
Reflect on interpretation of NHP immune responses in prediction of human responses