Vaccine Pre-clinical Toxicology Testing

Summary

Pre-clinical toxicology for vaccines is a necessary step in product development to assess what may be a safe starting dose for clinical trials and to identify potential toxicities to monitor in the clinical safety studies. Safety in animals is an important tool to help an Investigational New Drug (IND) sponsor and the FDA evaluate the potential risk of a novel product that has never before been in humans. This document provides a generic protocol design for repeated (episodic, not daily) dose toxicity studies applicable to most vaccine modalities and for genetic toxicity studies applicable to DNA vaccines and some vector-based vaccine approaches. Specific guidance on your vaccine candidate should be sought from the FDA and both this document and another cited reference (authored by one of us - SS) provide recommendations on how to go about getting that specific guidance from FDA.