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

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Study 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
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: 
10 Jan 2022
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

Information related to the decision procedure