A Phase I, randomized, double-blind, multi-centre, placebo-controlled, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational vaccine for the prevention of yellow fever (AVX70120), and of AstriVax’ inv

Study title: 
A Phase I, randomized, double-blind, multi-centre, placebo-controlled, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational vaccine for the prevention of yellow fever (AVX70120), and of AstriVax’ inv
Long title: 
A Phase I, randomized, double-blind, multi-centre, placebo-controlled, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational vaccine for the prevention of yellow fever (AVX70120), and of AstriVax’ investigational vaccine for the prevention of rabies (AVX70481), in healthy adults aged 18 to 40 years
Date receipt dossier: 
15 dec 2023
EU record number: 
B/BE/23/BVW3
Company / Sponsor: 
AstriVax NV
Phase: 
I
Treated organism: 
Humans
Indication category: 
Vaccination
Disease: 
Yellow Fever and Rabies
Therapeutic approach: 
Prevention
Genetic modification: 
Full genome of the live attenuated yellow fever virus (YFV) strain 17D (YF17D) containing the sequence of the surface glycoprotein from the rabies virus (RabG)
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: 
Universitair Ziekenhuis Gent (Ghent) Centre for Evaluation of Vaccination / Vaccinopolis (Antwerp)
Nr of subjects: 
48
Foreseen duration: 
From August 2024 until December 2025
Type of procedure: 
Contained use and Deliberate release
Current status: 
Assessed

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