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
A phase I/IB randomized, double-blind, placebo controlled dose finding study to evaluate the safety, tolerability, and immune response of single and multiple dose of the hepatitis B specific replication-defective adenovirus serotype 5 (Ad5) vector based vaccine, TG1050, and an initial evaluation of immunologic and antiviral activity in the treatment of patients with chronic hepatitis B infection

Proposed period of release:
01/09/2014 to 31/12/2017

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

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:
DNA Virus

Identity of the GMO:
Genus: Mastadenovirus
Species: human adenovirus serotype 5 (Ad5)

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
human serotype 5 (Ad5)Mastadenovirushuman adenovirussubgroup Chuman serotype 5

European Commission administrative information

Consent given by the Member State Competent Authority:
01/04/2015 00:00:00