B/BE/09/BVW1 - Summary Notification Information Format (SNIF)Public information presented according to the provisions of Directive 2001/18/EC
Long title
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu (plaque forming units) of RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection
EU record number
B/BE/09/BVW1
EudraCT number
2008-006946-24
Company / Sponsor
N.V. Roche S.A.
Phase
II
Treated organism
Humans
Indication category
Cancer therapy
Disease
cervical neoplasia
Therapeutic approach
Immunotherapy
Genetic modification
E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2)
Method of transfer of nucleic acid of interest
Modified Vaccinia virus Ankara (MVA)
Administered biological material
Recombinant Attenuated Vaccinia virus
Route of administration
subcutaneous
Locations in Belgium
Flanders, Wallonia and Brussels as a consequence of the clinical trial conducted with patients recruited at UZ Brussel, UZ Gent, UZ Gasthuisberg (Leuven), UZ Antwerpen, AZ Middelheim (Antwerpen), AZ Heilig-Hart (Tienen), ULB Erasme (Brussels)
Nr of subjects
about 100 patients in Europe, 200 patients worldwide
Foreseen duration
13 months
Type of procedure
Contained use and Deliberate release
Current status
Authorized
Notes
trial completed - 17 patients included in Belgium
Pharmaceutical study code
NV25025