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

Study title: 
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: 
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study temporarily withdrawn by the notifier

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