Vaccine Pre-clinical Toxicology Testing

Scope of this document

This document is intended to provide HIV vaccine researchers with general advice on pre-clinical toxicology testing and pre-clinical product development to aid in translating research concepts into vaccine candidates suitable for human clinical trial testing. The recommendations provided in this document do not reflect official U.S. Food and Drug Administration (FDA) policy. As FDA guidance in this area is under development⁵, the reader is encouraged to contact the Office of Vaccines Research and Review (OVRR) in the Center for Biologics Evaluation and Research (CBER) at FDA regarding pre-clinical safety testing requirements for particular vaccine candidates to support investigational new drug applications. In addition, specific guidance on regulatory requirements for a particular product should be sought from the FDA (www.fda.gov/cber). This document will provide advice on pre-clinical toxicology study designs, in general, and with additional focus on specialized toxicology studies for DNA plasmid vaccines. Many of the resources needed to accomplish this translation of research concepts into actual product vaccine candidates may be requested from the National Institutes of Health's Division of AIDS (http://www.niaid.nih.gov/daids/vaccine/funding.htm and http://www.niaid.nih.gov/daids/vaccine/investigators.htm).