B/BE/07/BVW3 -Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever) Public information presented according to the provisions of Directive 2001/18/EC
EU record number
B/BE/07/BVW3
Company / Sponsor
GENimmune N.V.
Phase
I
Treated organism
Humans
Indication category
Hepatic disorders
Disease
Chronic hepatitis B
Therapeutic approach
Immunotherapy
Genetic modification
Hepatitis B virus polyepitope gene
Method of transfer of nucleic acid of interest
Modified Vaccinia virus strain MVATGN33
Administered biological material
Recombinant Attenuated Vaccinia Virus
Route of administration
subcutaneous
Locations in Belgium
Flanders, Wallonia and Brussels as a consequence of clinical trials conducted with healthy volunteers and patients from all the country potentially recruited at: - Centre Hospitalier Universitaire Brugmann, Brussels, - Cliniques Universitaires Saint-Luc, Brussels, - Drug Reseach Unit Ghent (D.R.U.G.) Gent - SGS Life Science Services - Research Unit Stuivenberg, Antwerpen - Universitair Ziekenhuis Antwerpen, Antwerpen - Universitair Ziekenhuis Brussel, Brussels. - Universitair Ziekenhuis Gasthuisberg, Leuven, and - Universitair Ziekenhuis Gent, Gent.
Nr of subjects
15 healthy volunteers + 15 patients
Foreseen duration
2 years
Type of procedure
Contained use and Deliberate release
Notes
study temporarily withdrawn by the notifier