B/BE/24/BVW6 - Informationsblatt für die Öffentlichkeit (vom Anmelder erstellt)Public information according to the provisions of Directive 2001/18/EC
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
HBV (CHB) infection
Date receipt dossier
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
Authorized