Long title
A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [live, attenuated]) in Healthy Adults
Date receipt dossier
EU record number
B/BE/21/BVW9
EudraCT number
2020-004501-30
Company / Sponsor
ActoGenix
Phase
II
Treated organism
Humans
Indication category
Vaccination
Disease
Dengue disease
Therapeutic approach
Prevention
Genetic modification
V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30)
Method of transfer of nucleic acid of interest
N/A
Administered biological material
Attenuated virus
Route of administration
Subcutaneous
Locations in Belgium
UZ Gent, CHU Saint-Pierre Brussels, Instituut voor Tropische Geneeskunde Antwerpen, ANIMA Research Center Alken
Nr of subjects
Up to 185 patients in Belgium
Foreseen duration
From 09 August 2022 till 12 August 2025
Type of procedure
Contained use and Deliberate release
Notes
Dossier withdrawn by the notifier on 12 August 2022