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Review
. 2013 Dec;13(6):385-94.
doi: 10.2174/15665232113136660005.

General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination

Aline Baldo, Eric van den Akker, Hans E Bergmans, Filip Lim, Katia Pauwels  1
Affiliations
Free PMC article
Review

General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination

Aline Baldo et al. Curr Gene Ther. 2013 Dec.
Free PMC article

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.

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Fig. (1)
Fig. (1)
Standard steps in an environmental risk assessment. For explanation see main text.
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References

    1. Bleijs DA, Haenen ITWC, Bergmans JEN. Gene therapy legislation in the Netherlands. J Gene Med. 2007;9:904–9. - PubMed
    1. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws. regulations and administrative provisions of the Member. States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Off J 01 05. 2001;L121:34. - PubMed
    1. Directive 2001/18/EC of the European parliament and of the Council of 12 March on the deliberate release into the environment of genetically modified organisms and repealing. Council Directive 90/220/EEC Off J 17 04. 2001;L106:1.
    1. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 march 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off J 30 04. 2004;L136:1.
    1. Directive 2009/41/EC of the European Parliament and of the council of 6 May 2009.On the contained use of genetically modified micro-organisms. (Recast) Off J. 21 05. 2009;L125:0075.

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