Phase I study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects

Study title: 
Phase I study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects
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: 
26 Apr 2021
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

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