FDA guidance on prophylactic DNA vaccines: Analysis and recommendations

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...

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Bibliographic Details
Published inVaccine Vol. 28; no. 16; pp. 2801 - 2805
Main Authors Klinman, Dennis M, Klaschik, Sven, Tross, Debra, Shirota, Hidekazu, Steinhagen, Folkert
Format Journal Article
LanguageEnglish
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
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Summary: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 in this field.
Bibliography:ObjectType-Article-1
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ObjectType-Review-3
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ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2009.11.025