Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
A Phase II randomized, placebo-controlled trial of vedolizumab with or without HIV MVA vaccine in individuals who started antiretrovirals during primary or chronic infection (EHVA T02/ANRS VRI07).

Proposed period of release:
01/03/2020 to 31/05/2021

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?
Germany; Spain; France; United Kingdom; Italy; Sweden;

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

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 "gag-pol-nef" from the HIV-1 clade B virus has been inserted into the MVA.

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:
Not known