title: Preclinical and clinical safety studies on DNA vaccines.
abstract: DNA vaccines are based on the transfer of genetic material, encoding an antigen, to the cells of the vaccine recipient. Despite high expectations of DNA vaccines as a result of promising preclinical data their clinical utility remains unproven. However, much data is gathered in preclinical and clinical studies about the safety of DNA vaccines. Here we review current knowledge about the safety of DNA vaccines. Safety concerns of DNA vaccines relate to genetic, immunologic, toxic, and environmental effects. In this review we provide an overview of findings related to the safety of DNA vaccines, obtained so far. We conclude that the potential risks of DNA vaccines are minimal. However, their safety issues may differ case-by-case, and they should be treated accordingly.
authors.affiliation: Centre for Biological Medicines and Medical Technology, National Institute for Public Health and the Environment, Bilthoven, The Netherlands. marjolijn.schalk@rivm.nl
authors.forename: Johanna A C
authors.initials: JA
authors.lastname: Schalk
authors.forename: Frits R
authors.initials: FR
authors.lastname: Mooi
authors.forename: Guy A M
authors.initials: GA
authors.lastname: Berbers
authors.forename: Leon A G J M
authors.initials: LA
authors.lastname: van Aerts
authors.forename: Hans
authors.initials: H
authors.lastname: Ovelgönne
authors.forename: Tjeerd G
authors.initials: TG
authors.lastname: Kimman
mesh_terms: D000818:Animals; D001327:Autoimmune Diseases / Q000209:etiology; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D004777:Environment; D006801:Humans; D007108:Immune Tolerance; D007883:Legislation, Medical; D012306:Risk; D019444:Vaccines, DNA / Q000009:adverse effects* / Q000493:pharmacokinetics
chemical_list: D019444:Vaccines, DNA