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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 Name	Genus	Species	Subspecies	Strain	Pathovar
MVA	Orthopox virus	vaccinia	-	Modified Virus Ankara	-

European Commission administrative information

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