title: General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination.
abstract: This introductory paper gathers general considerations on the biosafety of virus-derived vectors that are used in human gene therapy and/or vaccination. The importance to assess the potential risks for human health and the environment related to the use of genetically modified organisms (GMO) in this case genetically modified viral vectors is highlighted by several examples. This environmental risk assessment is one of the requirements within the European regulatory framework covering the conduct of clinical trials using GMO. Risk assessment methodologies for the environmental risk assessment of genetically modified virus-derived vectors have been developed.
authors.forename: Aline
authors.initials: A
authors.lastname: Baldo
authors.forename: Eric
authors.initials: E
authors.lastname: van den Akker
authors.forename: Hans E
authors.initials: HE
authors.lastname: Bergmans
authors.forename: Filip
authors.initials: F
authors.lastname: Lim
authors.affiliation: Scientific Institute of Public Health (WIV-ISP), Biosafety and Biotechnology Unit, Rue J. Wytsmanstraat 14, B-1050 Brussels, Belgium. aline.baldo@wiv-isp.be.
authors.forename: Katia
authors.initials: K
authors.lastname: Pauwels
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D015316:Genetic Therapy / Q000009:adverse effects* / Q000379:methods*; D005822:Genetic Vectors / Q000008:administration & dosage* / Q000009:adverse effects*; D015386:Hazardous Substances / Q000009:adverse effects; D006801:Humans; D030781:Organisms, Genetically Modified / Q000235:genetics; D018570:Risk Assessment; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*; D014780:Viruses / Q000235:genetics*
chemical_list: D015386:Hazardous Substances