Assuring the quality, safety, and efficacy of DNA vaccines

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 as a result of the starting material often being developed in a research laboratory under ill-defined conditions. This chapter examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations which must be addressed during nonclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinee's chromosomes and the potential for the formation of anti-DNA antibodies.