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Notification report


Full notification file


General information

Notification Number
B/ES/19/03

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
27/12/2018

Title of the Project
A Phase I/II randomized therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection (EVHA T01/ANRS VRI05)

Proposed period of release:
01/04/2019 to 30/04/2022

Name of the Institute(s) or Company(ies)
Inserm-ANRS, French National Institute for Health and Medical Research-ANRS (France Recherche Nord & Sud- HIV Hépatites), Paris, France.;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Germany; Spain; France; United Kingdom; Italy; Sweden;

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/FR/13/GT03;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Modified vaccinia Ankara virus -based anti-HIV vaccine (named MVATG17401 or MVA HIV-B in the clinical trial)

Genus: Orthopoxvirus Species: Vaccinia virus

• 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.
• A transgene that codes for the poliprotein


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
05/06/2019 00:00:00
Remarks: