B/BE/23/BVW3 - Informationsblatt für die Öffentlichkeit (vom Anmelder erstellt)Public information according to the provisions of Directive 2001/18/EC
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
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)
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
Authorized