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Notification report


Full notification file


General information

Notification Number
B/BE/21/BVW2

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
26/04/2021

Title of the Project
Phase I, single-centre, randomized, double blind, placebo-controlled study to assess safety, tolerability and immunogenicity of hRVFV-4s vaccine in healthy subjects

Proposed period of release:
01/11/2021 to 24/10/2022

Name of the Institute(s) or Company(ies)
Wageningen Bioveterinary Research, ;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
RNA Virus

Identity of the GMO:
Order: Bunyavirales
Family: Phenuiviridae (formerly Bunyaviridae)
Genus: Phlebovirus
Species: Rift Valley fever virus
Strain: Clone 13
Vaccine name: hRVFV-4s


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Clone 13BhlebovirusRift Valley fever virus-Clone 13Veterinary vaccine strain

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known