B/BE/21/BVW6 - Fiche d'information destinée au public (préparée par le notifiant)Public information according to the provisions of Directive 2001/18/EC
Long title
A phase 2, single-blinded, randomized, controlled multi-country study to evaluate the safety,reactogenicity, efficacy and immune response following sequential treatment with an antisense oligonucleotide (ASO) against chronic Hepatitis B (CHB) followed by chronic Hepatitis B targeted immunotherapy (CHB-TI) in CHB patients
Date receipt dossier
EU record number
B/BE/21/BVW6
EudraCT number
2021-003567-10
Company / Sponsor
GlaxoSmithKline Biologicals SA
Phase
II
Treated organism
Humans
Indication category
therapeutic vaccine
Disease
Chronic Hepatitis B
Therapeutic approach
Immunotherapy
Genetic modification
Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus serotype 155 viral vector and a Modified Vaccinia Ankara virus (MVA) construct, both encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens
Method of transfer of nucleic acid of interest
Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus serotype 155 (ChAd155) and a Modified Vaccinia Ankara virus (MVA) construct
Administered biological material
Recombinant viruses
Route of administration
Intramuscular
Locations in Belgium
UZ Antwerpen, SGS Life Science Service
Nr of subjects
Up to 7 in Belgium (total of 184 patients for the trial)
Foreseen duration
between 9-12 months starting from Q1- 2022, followed by follow-up for 3 years
Type of procedure
Contained use and Deliberate release
Current status
Authorized