DNA vaccines

This document reflects the need for a revised guideline on the quality, non-clinical and clinical aspects associated with DNA vaccines.

Keywords: DNA vaccines, bacterial plasmid DNA, prevention of infectious diseases, gene, antigen, biodistribution, persistence, chromosomal integration

Current version

Concept paper on guidance for DNA vaccines

Draft: consultation closed Consultation dates: 30/03/2012 to 30/06/2012 Reference Number: EMEA/CHMP/308136/2007 Summary:

DNA vaccines against infectious diseases have been under development for some time and DNA vaccines expressing HIV or malaria antigens have especially been targeted. Although to date no marketing authorisations for such a vaccine for human use have been granted in the European Union, the first DNA vaccines for veterinary use, West Nile-Innovator and Apex-IHN, have been authorised elsewhere.

Document history - First version (current)

Concept paper on guidance for DNA vaccines

Draft: consultation closed Consultation dates: 30/03/2012 to 30/06/2012 Reference Number: EMEA/CHMP/308136/2007 Summary:

DNA vaccines against infectious diseases have been under development for some time and DNA vaccines expressing HIV or malaria antigens have especially been targeted. Although to date no marketing authorisations for such a vaccine for human use have been granted in the European Union, the first DNA vaccines for veterinary use, West Nile-Innovator and Apex-IHN, have been authorised elsewhere.

Concept paper on guidance for DNA vaccines

Draft: consultation closed Reference Number: EMEA/CHMP/308136/2007