FDA guidance on prophylactic DNA vaccines: Analysis and recommendations

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

Research output: Contribution to journalComment/debate

54 Citations (Scopus)


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 languageEnglish
Pages (from-to)2801-2805
Number of pages5
Issue number16
Publication statusPublished - 2010 Apr 1


  • Clinical trials
  • DNA vaccines
  • Guidance


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