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

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

Volume: 13 Issue: 6

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

Affiliation:

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

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.

Cite this article as:

Baldo Aline, den Akker van Eric, Bergmans E. Hans, Lim Filip and Pauwels Katia, General Considerations on the Biosafety of Virus-derived Vectors Used in Gene Therapy and Vaccination, Current Gene Therapy 2013; 13 (6) . https://dx.doi.org/10.2174/15665232113136660005