B/BE/09/BVW1

Company/Institution	N.V. Roche S.A.
Parental organism	Modified Vaccinia virus Ankara (MVA)
Transgene(s)	E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2)
Treated organism	Humans
Title of the project	A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 107 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 a
Treatment indication	High grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection
Administration route(s)	subcutaneous
Total number of subjects foreseen	about 100 patients in Europe, 200 patients worldwide
Foreseen duration of release	13 months
Effective year(s) of release
Current status	Authorisation received on 17/12/2009 - clinical trial running
Locations	Flanders, Wallonia and Brussels as a consequence of the clinical trial conducted with patients potentially recruited at UZ Brussel, UZ Gent, UZ Gasthuisberg (Leuven), UZ Antwerpen, AZ Middelheim (Antwerpen), AZ Heilig-Hart (Tienen)
Number of sites	6 in Belgium
Monitoring
Type of procedure	Notification for deliberate release of GMO's other than higher plants for any other purpose than for placing on the market - submitted under the Royal Decree of 21 February 2005 on Deliberate release of genetically modified organisms - part B
Notes
Other

Information for the public

B/BE/09/BVW1 - Advice Biosafety Advisory Council
09 September 2009 : The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
B/BE/09/BVW1 - Decision of the Federal Ministers (FINAL DECISION)
17/12/2009: The Federal Ministers gives a final decision (positive with conditions) for this trial.