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
Intradermal vaccination with naked DNA encoding the fusion protein domain1 of tetanus toxin fragment C and MART-1(aa 26-35) for the induction of MART-1-specific T cell immunity in stage IV melanoma patients

Proposed period of release:
01/07/2010 to 01/07/2020

Name of the Institute(s) or Company(ies)
Leiden University Medical Center, Albinusdreef 2
2333 ZA Leiden
PO Box 9600
2300 RC Leiden
The Netherlands;

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:
Other: Plasmid

Identity of the GMO:
The medicinal product is not a GMO per se. It is an investigational gene therapy
medicinal product consisting of a purified plasmid DNA (pDNA) drug substance.
The plasmid DNA does not have a taxonomic classification.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known