A randomised, double-blind, placebo-controlled, single centre, Phase I study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational therapeutic hepatitis B virus (HBV) vaccine (AVX70371) in healthy adults aged 18 to 40 year

Study title: 
A randomised, double-blind, placebo-controlled, single centre, Phase I study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational therapeutic hepatitis B virus (HBV) vaccine (AVX70371) in healthy adults aged 18 to 40 year
Long title: 
A randomised, double-blind, placebo-controlled, single centre, Phase I study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational therapeutic hepatitis B virus (HBV) vaccine (AVX70371) in healthy adults aged 18 to 40 years
Date receipt dossier: 
24 Feb 2025
EU record number: 
B/BE/25/BVW2
EudraCT number: 
2025-521169-28
Company / Sponsor: 
AstriVax NV
Phase: 
I
Treated organism: 
Humans
Indication category: 
Vaccination
Disease: 
hepatitis B
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: 
Centrum voor vaccinologie (CEVAC) Ghent
Nr of subjects: 
16
Foreseen duration: 
from April 2025 till end 2026
Type of procedure: 
Contained use and Deliberate release
Current status: 
Assessed

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