FDA guidance on prophylactic DNA vaccines: Analysis and recommendations

• Published in: Vaccine Vol. 28; no. 16; pp. 2801 - 2805
• Main Authors: Klinman, Dennis M, Klaschik, Sven, Tross, Debra, Shirota, Hidekazu, Steinhagen, Folkert
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.04.2010; Elsevier; Elsevier Limited
• Subjects: Allergy and Immunology; Applied microbiology; Autoimmune diseases; Biological and medical sciences; Clinical trials; Clinical Trials as Topic; Deoxyribonucleic acid; DNA; DNA vaccines; Drug Approval - history; Drug Approval - methods; Drug dosages; Fundamental and applied biological sciences. Psychology; Guidance; Guidelines as Topic; History, 20th Century; History, 21st Century; Humans; Microbiology; Pharmaceutical industry; Plasmids; Proteins; Studies; United States; United States Food and Drug Administration; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, DNA - immunology; United States; United States > US; Guidance; Clinical trials; DNA vaccines; Prevention; Clinical trial; Genetic vaccine

Abstract The FDA has been regulating the conduct of prophylactic DNA vaccine trials in the US for nearly 15 years. This work describes the evolution of FDA policy over that period, the status of current regulatory guidance, and provides recommendations for further changes to facilitate development i...