FDA guidance on prophylactic DNA vaccines: Analysis and recommendations

Dennis M. Klinman; Sven Klaschik; Debra Tross; Hidekazu Shirota; Folkert Steinhagen

doi:10.1016/j.vaccine.2009.11.025

FDA guidance on prophylactic DNA vaccines: Analysis and recommendations

Dennis M. Klinman, Sven Klaschik, Debra Tross, Hidekazu Shirota, Folkert Steinhagen

Research output: Contribution to journal › Comment/debate › peer-review

42 Citations (Scopus)

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.

Original language	English
Pages (from-to)	2801-2805
Number of pages	5
Journal	Vaccine
Volume	28
Issue number	16
DOIs	https://doi.org/10.1016/j.vaccine.2009.11.025
Publication status	Published - 2010 Apr 1
Externally published	Yes

Keywords

Clinical trials
DNA vaccines
Guidance

ASJC Scopus subject areas

Molecular Medicine
Immunology and Microbiology(all)
veterinary(all)
Public Health, Environmental and Occupational Health
Infectious Diseases

Access to Document

10.1016/j.vaccine.2009.11.025

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