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Notification report


Full notification file


General information

Notification Number
B/FR/13/GT03

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
04/06/2013

Title of the Project
Phase I/II open-label randomized multicenter trial to assess immunogenicity and safety of 4 prime-boost combinations of HIV vaccine candidates (MVA HIV-B/LIPO-5; LIPO-5/MVA HIV-B; GTU-MultiHIV B/LIPO-5; GTU-MultiHIV B/MVA HIV-B) in healthy volunteers at low risk of HIV infection (ANRS VRI01)

Proposed period of release:
01/12/2013 to 31/01/2015

Name of the Institute(s) or Company(ies)
Institut national de la santé et de la recherche médicale, Agence nationale de recherches sur le sida et
les hépatites virales (Inserm-ANRS)
101 rue de Tolbiac
75013 PARIS;


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:
Other: Naked plasmid DNA

Identity of the GMO:
GTU-MultiHIV B Naked Plasmid DNA Vaccine

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Escherichia coli AG-1EscherichiacoliN/AAG-1. Brasilense Sp245N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known