B/BE/18/BVW4 - Summary Notification Information Format (SNIF) Public information presented according to the provisions of Directive 2001/18/EC
Long title
A first-time-in human (FTIH), Phase I, randomized, multi-centric, single-blind, controlled dose-escalation study to evaluate the reactogenicity, safety immunogenicity and efficacy of GSK Biologicals’ HBV viral vectored vaccines given in a prime-boost schedule with sequential or co-administration of adjuvanted proteins therapeutic vaccine (GSK3528869A) in chronic Hepatitis B patients (18-65 years old) well controlled under nucleo(s)tides analogues (NA) therapy
Date receipt dossier
EU record number
B/BE/18/BVW4
EudraCT number
2017-001452-55
Company / Sponsor
GlaxoSmithKline Biologicals SA
Phase
I
Treated organism
Humans
Indication category
Vaccination
Disease
Chronic Hepatitis B
Therapeutic approach
Prevention
Genetic modification
The study involves two GMOs. The GMO ChAd155-hIi-HBV is a viral suspension of a recombinant replication-defective simian (chimpanzee-derived) group C adenovirus serotype 155 (ChAd155) viral vector encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens. The GMO MVA-HBV is a modified vaccinia virus Ankara vector (MVA) encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens.
Method of transfer of nucleic acid of interest
Replication-defective simian (chimpanzee-derived) group C adenovirus, and modified vaccinia virus Ankara vector (MVA)
Administered biological material
Recombinant viruses
Route of administration
Intramuscular
Locations in Belgium
Hôpital Erasme (Brussels), UZ Gent (Ghent), UZ Antwerpen (Edegem), SGS Life Science Services (Antwerpen), UZ Leuven (Leuven), Cliniques Universitaires Saint-Luc (Brussels)
Nr of subjects
The study will enrol 148 patients.
Foreseen duration
The study will last approximatively 4.5 years.
Type of procedure
Contained use and Deliberate release
Current status
Authorized
Pharmaceutical study code
204852