DNA vaccines: development, standardization and regulation.

Nucleic acid vaccines contain nonvectored nucleic acids intended to be used as prophylactic vaccines in humans or animals. In addition to the Guidelines Assuring the Quality of DNA Vaccines published by the WHO, further standards for the manufacture and preclinical testing are being developed. Theoretical risks have been taken into account and assessed before human use has been considered. Legal requirements for clinical trials and licensing of nucleic vaccines are in place in Germany and other European member states which allow further testing and development of proprietary medicinal products based on nucleic acids and intended for prophylactic vaccination. Copyright 2001 S. Karger AG, Basel.