The approach for the nonclinical safety assessment of prophylactic vaccines for infectious diseases is well-established, with several regulatory guidelines and numerous examples of toxicology studies available in the literature and product approval packages. In contrast, there are few regulatory guidelines covering the nonclinical safety assessment of therapeutic vaccines and limited examples available in the public domain, although the number of therapeutic vaccines entering development continues to grow; including vaccines for cancer, Alzheimer’s disease, and other chronic conditions.

This session will start by providing an overview of the regulatory guidelines and general approach for the nonclinical safety assessment and toxicology studies designs for prophylactic vaccines. This will be followed by a discussion highlighting the similarities and differences with the approach used for therapeutic vaccines. Case studies will be used to illustrate points for consideration with respect to repeat dose and developmental and reproductive toxicity, and other evaluations that may be necessary based on modality and indication.