Back

Notification report


Full notification file


General information

Notification Number
B/DE/11/PEI1332

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
27/04/2011

Title of the Project
The project, CVC-MP-TG4040-01 clinical trial, is entitled “Open-label, phase I study combining prime injections of ChronVac-C (DNA-HCV) electroporated with MedPulser DNA delivery system (MedPulser DSS) with boost injections of TG4040 (MVA-HCV) in treatment-naïve subjects chronically infected with hepatitis C virus (HCV genotype 1)”.

Proposed period of release:
01/09/2011 to 31/12/2012

Name of the Institute(s) or Company(ies)
Transgene S.A., ;


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:
DNA Virus

Identity of the GMO:
The final GMO is TG4040 and consists of recombinant MVA vector particles (MVATG16643) in suspension in a formulation solution. MVATG16643 is a non integrative, poorly replicative, non propagative, recombinant vaccinia vector consisting of the modified vaccinia virus of Ankara (MVA) genome containing nucleotide sequences encoding Hepatitis C virus (HCV) non structural proteins NS3, NS4 and NS5B.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
MVAOrthopox virusvaccinia-Modified Virus Ankara-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
06/10/2011 00:00:00
Remarks: