Molecular Biotechnology

, Volume 17, Issue 2, pp 143–149 | Cite as

Assuring the quality, safety, and efficacy of DNA vaccines

  • James S. RobertsonEmail author
  • Elwyn Griffiths


Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. It is useful for such scientists to be aware of these processes as the development of a novel vaccine could be problematic owing to the starting material often being developed in a research laboratory under ill-defined conditions. This paper examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations that must be addressed during preclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinees chromosomes, and the potential for the formation of anti-DNA antibodies.

Index Entries

DNA vaccines regulatory process quality preclinical safety 


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Copyright information

© Humana Press Inc 2001

Authors and Affiliations

  1. 1.National Institute for Biological Standards and ControlPotters BarUK

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