A randomised, double-blind, placebo-controlled, multi-centre, Phase I study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational therapeutic hepatitis B virus (HBV) vaccine (AVX70371) in adult patients with chronic HBV

Study title: 
A randomised, double-blind, placebo-controlled, multi-centre, Phase I study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational therapeutic hepatitis B virus (HBV) vaccine (AVX70371) in adult patients with chronic HBV
Long title: 
A randomised, double-blind, placebo-controlled, multi-centre, Phase I study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational therapeutic hepatitis B virus (HBV) vaccine (AVX70371) in adult patients with chronic HBV (CHB) infection
Date receipt dossier: 
15 Oct 2024
EU record number: 
B/BE/24/BVW6
EudraCT number: 
2024-518874-15
Company / Sponsor: 
AstriVax NV
Phase: 
I
Treated organism: 
Humans
Indication category: 
Vaccination
Disease: 
hepatitis B virus (HBV)
Therapeutic approach: 
Prevention
Genetic modification: 
Full genome of the live attenuated yellow fever virus (YFV) strain 17D (YF17D) containing the sequence of the HBV core antigen (HBc)
Method of transfer of nucleic acid of interest: 
Plasmid-launched live attenuated virus (PLLAV)
Administered biological material: 
Genetically modified virus
Route of administration: 
Intradermal
Locations in Belgium: 
SGS Belgium N.V., Edegem (Antwerp)
Nr of subjects: 
40
Foreseen duration: 
from March 2025 till end 2026
Type of procedure: 
Contained use and Deliberate release
Current status: 
Under evaluation

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