Current Gene Therapy

Ignacio Anegon
Director INSERM UMR 1064-Center for Research in Transplantation and Immunology
CHU de Nantes. 30, boulevard


General Considerations on the Biosafety of Virus-derived Vectors Used in Gene Therapy and Vaccination

Author(s): Aline Baldo, Eric van den Akker, Hans E. Bergmans, Filip Lim and Katia Pauwels

Affiliation: Scientific Institute of Public Health (WIV-ISP), Biosafety and Biotechnology Unit, Rue J. Wytsmanstraat 14, B-1050 Brussels, Belgium.


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.

Keywords: Biosafety, environmental risk assessment, gene therapy, genetically modified organisms, vaccination, viral vectors.

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Article Details

Page: [385 - 394]
Pages: 10
DOI: 10.2174/15665232113136660005