A first-time-in human, Phase I, study to evaluate the reactogenicity, safety immunogenicity and efficacy of HBV viral vectored vaccines given in a prime-boost schedule in chronic Hepatitis B patients

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Study title: 
A first-time-in human, Phase I, study to evaluate the reactogenicity, safety immunogenicity and efficacy of HBV viral vectored vaccines given in a prime-boost schedule in chronic Hepatitis B patients
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: 
19 jul 2018
EU record number: 
B/BE/18/BVW4
EudraCT number: 
2017-001452-55
Pharmaceutical study code: 
204852
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

Information related to the decision procedure