title: Environmental risk assessment of clinical trials involving modified vaccinia virus Ankara (MVA)-based vectors.
abstract: The modified vaccinia virus Ankara (MVA) strain, which has been developed as a vaccine against smallpox, is since the nineties widely tested in clinical trials as recombinant vector for vaccination or gene therapy applications. Although MVA is renowned for its safety, several biosafety aspects need to be considered when performing the risk assessment of a recombinant MVA (rMVA). This paper presents the biosafety issues and the main lessons learned from the evaluation of the clinical trials with rMVA performed in Belgium. Factors such as the specific characteristics of the rMVA, the inserted foreign sequences/transgene, its ability for reconversion, recombination and dissemination in the population and the environment are the main points of attention. Measures to prevent or manage identified risks are also discussed.
authors.forename: Martine
authors.initials: M
authors.lastname: Goossens
authors.forename: Katia
authors.initials: K
authors.lastname: Pauwels
authors.forename: Nicolas
authors.initials: N
authors.lastname: Willemarck
authors.affiliation: Scientific Institute of Public Health, Biosafety and Biotechnology Unit, Rue J. Wytsmanstraat 14, B- 1050 Brussels, Belgium. martine.goossens@wiv-isp.be.
authors.forename: Didier
authors.initials: D
authors.lastname: Breyer
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D015316:Genetic Therapy / Q000009:adverse effects* / Q000379:methods* / Q000592:standards; D005822:Genetic Vectors / Q000008:administration & dosage / Q000009:adverse effects* / Q000235:genetics; D015386:Hazardous Substances / Q000009:adverse effects; D006801:Humans; D018570:Risk Assessment; D014611:Vaccination / Q000009:adverse effects / Q000379:methods; D014616:Vaccinia virus / Q000235:genetics* / Q000276:immunology; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics
chemical_list: D015386:Hazardous Substances; D014765:Viral Vaccines