Chapter 25 Preclinical Toxicology of Vaccines 1

Green, Martin David; Hussain Al-Humadi, Nabil

Immunity to targeted infectious diseases may be conferred or enhanced by vaccines, which are manufactured from recombinant forms as well as inactivated or attenuated organisms. These vaccines have to meet requirements for safety, quality and efficacy. In addition to antigenic components, various adjuvants may be included in vaccines to evoke an effective immune response. To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. Successful preclinical toxicology studies depend on multiple factors including: using the appropriate study designs, using the right animal model, and evoking an effective immune response. Additional in vivo and in vitro assays that establish the identity, purity, safety, and potency of the vaccine play a significant role in assessing critical characteristics of vaccine safety.