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Notification report


Full notification file


General information

Notification Number
B/NL/20/010

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
07/08/2020

Title of the Project
A two-center, randomized, double-blind, placebo-controlled, phase Ib study to assess thesafety, tolerability and immunogenicity of two ascending doses of the candidate vaccineMVA-MERS-S_DF-1 in healthy study subjects

Proposed period of release:
01/11/2020 to 30/11/2021

Name of the Institute(s) or Company(ies)
Erasmus MC, Erasmus MC
s-Gravendijkwal 230
Afdeling Urologie
Rotterdam 3015 CE
The Netherlands;
Universitätsklinikum Hamburg-Eppendorf (UKE), ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Germany;

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

If yes, notification number(s):


GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Recombinant Modified Vaccinia Virus Ankara (MVA) delivering the S-glycoprotein of the Middle East Respiratory Syndrome (MERS) coronavirus (CoV), manufactured on chicken fibroblast cell line DF-1: MVA-MERS-S_DF-1 (Song et al., 2013).
Genus: Orthopoxvirus
Species: Vaccinia virus


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-Orthopoxvirusvaccinia-Modified vaccinia virus Ankara-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
02/11/2020 00:00:00
Remarks: