DNA/plasmid vaccine

Sheets RL, Stein J, Manetz TS, Andrews C, Bailer R, Rathmann J, Gomez PL. Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, ebola, severe acute respiratory syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts. Toxicol Scis 2006 91 620-30. 

Other guidelines exist, are more specific (e.g., for influenza, smallpox vaccines), or cover specific topics (e.g., adjuvants). Brennan and Dougan2 and Dempster and Howarth3 present a list of the most relevant guidelines. Also of note is the fact that guidelines may differ between countries for example, Japan considers a DNA/plasmid vaccine a gene therapy product. All pivotal studies should be conducted in compliance with Good Laboratory Practice (GLP).18... 

---