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Notification report


Full notification file


General information

Notification Number
B/BE/12/BVW1

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
04/05/2012

Title of the Project
A multi‐center, randomized, double‐blind, placebo‐controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination at 5.106 TU, 5.107 TU or 5.108 TU doses to placebo in HIV‐1 clade B infected patients under highly active antiretroviral therapy (HAART)

Proposed period of release:
01/01/2012 to 31/07/2013

Name of the Institute(s) or Company(ies)
THERAVECTYS, Pasteur Biotop building
28 rue du Dr ROUX
75015 Paris ‐ FRANCE;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
France;

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
RNA Virus

Identity of the GMO:
The THV01 investigational vaccine comprises two GMOs, THV01-1 and THV01-2, to be injected
successively in HIV-infected patients.
THV01-1 and THV01-2 are two live recombinant viral vectored vaccines derived from the NL4-3
strain of the HIV-1. They are non-replicative and self-inactivating vectors due to a deletion of the
U3 region in the 3’ and 5’ LTR. They are non-pathogenic as all accessory genes from the parental
virus (HIV) have been removed.
Both GMOs encode the same HIV transgene, composed of peptides of the HIV-1 clade B, Gag, Pol and Nef proteins under the regulation of a THERAVECTYS patented human promoter. This transgene is non-functional.
The GMOs are pseudotyped by two different serotypes of the G protein of the vesicular stomatitis virus (VSV.G)


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Lentiviral vectorsLentivirusHuman immunodeficiency virus (HIV)HIV‐1vector derived from the NL4‐3 strain-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known