title: Assuring the quality, safety, and efficacy of DNA vaccines.
abstract: Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. It is useful for such scientists to be aware of these processes, as the development of a novel vaccine could be problematic as a result of the starting material often being developed in a research laboratory under ill-defined conditions. This chapter examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations which must be addressed during nonclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinee's chromosomes and the potential for the formation of anti-DNA antibodies.
authors.affiliation: National Institute for Biological Standards and Control, Herts, UK.
authors.forename: James S
authors.initials: JS
authors.lastname: Robertson
authors.forename: Elwyn
authors.initials: E
authors.lastname: Griffiths
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods; D004353:Drug Evaluation, Preclinical / Q000379:methods; D005062:European Union; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration; D019444:Vaccines, DNA / Q000009:adverse effects; D014944:World Health Organization
chemical_list: D019444:Vaccines, DNA