title: Regulation and review of DNA vaccine products.
abstract: Research efforts to develop DNA vaccine products have progressed to the clinical evaluation of several vaccine candidates. These clinical trials are assessing safety and immunogenicity and whether different routes and schedules of administration can improve immune responses. Vaccine candidates under study include those for hepatitis B, HSV-2, HIV-1, influenza, and malaria. Unique safety concerns include the potential for genomic integration, biodistribution, tolerance and auto-immunity. CBER has issued a Points to Consider (PTC) document outlining regulatory policy, recommendations for the development of consistent manufacturing processes, and the design of preclinical studies to establish the safety of DNA vaccine products. This presentation will provide an overview of DNA vaccine products currently under clinical evaluation and the regulatory policy that has guided their development.
authors.affiliation: DVRPA/OVRR/CBER/FDA, Rockville, MD 20852, USA.
authors.forename: H A
authors.initials: HA
authors.lastname: Smith
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000592:standards; D006801:Humans; D017387:Investigational New Drug Application; D011786:Quality Control; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration; D019444:Vaccines, DNA / Q000009:adverse effects / Q000592:standards*
chemical_list: D019444:Vaccines, DNA