B/BE/07/BVW3

Company/Institution	GENimmune N.V.
Parental organism	Modified Vaccinia virus strain MVATGN33
Transgene(s)	Hepatitis B virus polyepitope gene
Treated organism	Humans
Title of the project	A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients
Treatment indication	Chronic hepatitis B
Administration route(s)	subcutaneous
Total number of subjects foreseen	15 healthy volunteers + 15 patients
Foreseen duration of release	2 years
Effective year(s) of release	-
Current status	Authorized but study temporarily withdrawn by the notifier
Locations	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.
Number of sites	Potentially 8 in Belgium
Monitoring
Type of procedure	Standard procedure - Chapter II Royal Decree 21 February 2005
Notes
Other

Information for the public

B/BE/07/BVW3 - Advice of the Belgian Biosafety Advisory Council
07 March 2008: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
B/BE/07/BVW3 - Decision of the Federal Ministers (FINAL DECISION)
29 April 2008: The Federal Ministers gives a final decision (positive with conditions) for this trial.