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
EU record number:
Company / Sponsor:
Chronic hepatitis B
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:
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
Type of procedure:
Contained use and Deliberate release
study temporarily withdrawn by the notifier
Information for the public
Public information presented according to the provisions of Directive 2001/18/EC
Information related to the decision procedure
07 March 2008: The Biosafety Advisory Council issues a positive advice (with conditions) for this trial.
29 April 2008: The Federal Ministers gives a final decision (positive with conditions) for this trial.