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Notification report


Full notification file


General information

Notification Number
B/ES/15/12

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
26/10/2015

Title of the Project
AN OPEN LABEL PHASE I TRIAL TO EVALUATE THE SAFETY AND EFFECT OF HIVconsv VACCINES IN COMBINATION WITH HISTONE DEACETYLASE INHIBITOR ROMIDEPSIN ON THE VIRAL REBOUND KINETIC AFTER TREATMENT INTERRUPTION IN EARLY TREATED HIV-1 INFECTED INDIVIDUALS.

Proposed period of release:
01/02/2016 to 30/09/2016

Name of the Institute(s) or Company(ies)
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.HIVconsv. 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. To the MVA it has been inserted a transgene coding for the insert HIVconsv in order to induce an HIV-1 specific T cell immune response. The size of MVA.HIVconsv size after the insertion is estimated to be approximately 180 kbp.

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
14/12/2015 00:00:00
Remarks: