Full notification file
Member State to which the notification was sent
Date of acknowledgement from the Member State Competent Authority
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 5.10 10e6 TU, 5.0 10e7 TU or 5.0 10e8 TU doses to placebo in HIV-1 clade B infected patients under highly active antiretrovital 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?
Has the same GMO been notified elsewhere by the same notifier?
GMO is a:
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 clustered peptides and epitopes 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
Human immunodeficiency virus (HIV)
vector derived from the NL4-3 strain
European Commission administrative information
Consent given by the Member State Competent Authority: