Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

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?

Has the same GMO been notified elsewhere by the same notifier?

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