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Notification report


Full notification file


General information

Notification Number
B/ES/16/11

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
21/10/2016

Title of the Project
A phase I randomized, placebo-controlled trial, to evaluate the safety, tolerability and immunogenicity of experimental HIV-1 vaccines, DNA.HTI and MVA.HTI administered in HIV-1 negative volunteer adults (Aelix-oo1).

Proposed period of release:
01/02/2017 to 28/02/2018

Name of the Institute(s) or Company(ies)
Aelix Therapeutics, Aelix Therapeutics in collaboration with IrsiCaixa AIDS Research Institute
Hospital Universitari Germans Trias i Pujol Carretera de Canyet s/n
08916 Badalona (Barcelona);


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:
DNA Virus

Identity of the GMO:
The genetically modified organism (GMO) used in the trial is the MVA.HTI. The MVA vector is a modified vaccinia Ankara virus, live recombinant, attenuated by serial passages in cultured chicken embryo fibroblasts (CEF) with contains six large deletions from the parental virus genome. Within the MVA has been inserted a transgene coding for the insert HTI in order to induce an HIV-1 specific T cell immune response. The size of MVA.HTI after the insertion is estimated to be approximately 179.6 kp.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
MVAOrthopoxvirusvaccinia-Modified vaccinia virus Ankara-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
13/12/2016 00:00:00
Remarks: