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Notification report


Full notification file


General information

Notification Number
B/DE/20/PEI4025

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
27/02/2020

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


Proposed period of release:
01/10/2019 to 31/01/2021

Name of the Institute(s) or Company(ies)
Inserm-ANRS, French National Institute for Health and Medical Research-ANRS (France Recherche Nord & Sud- HIV H├ępatites), 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/DE/19/PEI3493;

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)


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
MVAorthopoxvirusvaccinia---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
27/10/2020 00:00:00
Remarks: