Safety considerations for nucleic acid vaccines.
Whilst it is premature to formulate guidelines for the manufacturing requirements of a nucleic acid vaccine, it can never be too early to discuss and debate the issues surrounding the use of a novel biotherapeutic. The major safety issues posed by nucleic acid vaccination include the possibility of transformation (or tumorigenic) events in recipients of a DNA vaccine, the potential formation of anti-DNA antibodies, and unexpected and untoward effects of long-term expression of a foreign antigen. This paper examines the extent to which these points impinge on the safety of DNA vaccines.
Robertson
J S
JS
National Institute for Biological Standards and Control, Herts, UK.
D000818:Animals; D000974:Antibodies, Antinuclear / Q000096:biosynthesis; D006801:Humans; D009696:Nucleic Acids / Q000009:adverse effects* / Q000592:standards*; D014170:Transformation, Genetic; D014612:Vaccines / Q000009:adverse effects* / Q000592:standards*
D000974:Antibodies, Antinuclear; D009696:Nucleic Acids; D014612:Vaccines