DNA vaccines
DNA vaccination consists of stimulating the immune system in a specific way to prevent or ameliorate diseases caused by infectious agents. Two different approaches have been used to induce protective immune responses: one utilizes the administration of antigenic inert substances (a structural component of the whole inactivated microbe) and the other is based on the use of highly attenuated infectious microorganisms which, upon administration, replicate within the host without causing disease, thus priming the immune system in the same manner as natural infection.
DNA Vaccine Standardization
Written standards
WHO guidance on the quality and non-clinical safety evaluation of DNA vaccines was adopted by the Expert Committee for Biological Standardization (ECBS) in 2005. This document was formulated to provide national regulatory authorities and vaccine manufacturers a scientifically sound basis for the production and control of DNA vaccines intended for use in humans, and to assure their consistent safety and efficacy provide information. The section on nonclinical development was drawn up in response to the use of different experimental approaches to enhancing the efficacy of DNA vaccines which may raise specific safety concerns. WHO has developed guidelines to ensure that appropriate production methods and quality control tests are used for the manufacture of plasmid DNA vaccines. It is recognized that the development and application of nucleic acid vaccines are evolving rapidly, and that these guidelines will need to be revised and expanded in the future. Until that time, the control of nucleic acid vaccines should be approached in a flexible manner so that experience can be gained in their production and use.