Approaches to Modelling the Human Immune Response in Transition of Candidates from Research to Development

摘要

This review considers the steps required to evaluate a candidate biodefense vaccine or therapy as it emerges from the research phase, in order to transition it to development. The options for preclinical modelling of efficacy are considered in the context of the FDA's Animal Rule. The development of any product for ultimate clinical use is a lengthy process, requiring the progression from proof-of-principle research into nonclinical models and safety testing and progressive phases of testing in humans, through clinical trials. The different phases of clinical trial are generally designed to progressively test the safety and immunogenicity of the candidate vaccine or therapy, usually starting with a dose-escalating design followed by dose and schedule optimisation, before pivotal trials at the selected dose and schedule.