B/BE/21/BVW2 - Summary Notification Information Format (SNIF)Public information presented according to the provisions of Directive 2001/18/EC
Long title
Phase I, single-centre, randomized, double blind, placebo-controlled study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects
Date receipt dossier
EU record number
B/BE/21/BVW2
EudraCT number
2020-003362-39
Company / Sponsor
Wageningen Bioveterinary Research (Larissa Consortium)
Phase
I
Treated organism
Humans
Indication category
Vaccination
Disease
Rift Valley Fever Virus Infection
Therapeutic approach
Prevention
Genetic modification
hRVFV-4s is a four segments human Rift Valley fever virus vaccine, which derives from a natural clone (Clone 13) that lacks 69% of the gene NSs, a major virulence determinant of the virus. The hRVFV-4s vaccine is further attenuated by splitting the M genome segment into two M-type segments.
Method of transfer of nucleic acid of interest
N/A
Administered biological material
Attenuated virus
Route of administration
Intramuscular
Locations in Belgium
Universitair Ziekenhuis Gent
Nr of subjects
75
Foreseen duration
From 01 November 2021 until 24 October 2022
Type of procedure
Contained use and Deliberate release
Current status
Assessed