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 owing to the starting material often being developed in a research laboratory under ill-defined conditions. This paper examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations that must be addressed during preclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinees chromosomes, and the potential for the formation of anti-DNA antibodies.
authors.affiliation: National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, UK. jrobertson@nibsc.ac.uk
authors.forename: J S
authors.initials: JS
authors.lastname: Robertson
authors.forename: E
authors.initials: E
authors.lastname: Griffiths
mesh_terms: D000818:Animals; D000974:Antibodies, Antinuclear / Q000096:biosynthesis; D002986:Clinical Trials as Topic; D016207:Cytokines / Q000235:genetics; D017277:Drug Approval; D004353:Drug Evaluation, Preclinical; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D008004:Licensure; D010957:Plasmids / Q000235:genetics / Q000302:isolation & purification; D011786:Quality Control; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration; D019444:Vaccines, DNA / Q000009:adverse effects / Q000494:pharmacology / Q000592:standards*; D014944:World Health Organization
chemical_list: D000974:Antibodies, Antinuclear; D016207:Cytokines; D019444:Vaccines, DNA