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Notification report


Full notification file


General information

Notification Number
B/ES/18/21

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
13/07/2018

Title of the Project
Phase IIa, randomized, double blind, placebo-controlled, first-in-human study of the safety, tolerability and immunogenicity of candidate vaccines MVA.HTI and ChAdOx1.HTI alone or administered sequentially with GS-9620 in HIV-1positive patients treated early (AELIX-003).

Proposed period of release:
30/09/2018 to 30/06/2020

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?
Yes:
Belgium; Denmark; Spain; France;

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

If yes, notification number(s):
B/ES/16/11;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Family: Adenoviridae
Genus: Mastadenovirus
Species: attenuated chimpanzee adenovirus, without replication capacity, derived from serotype Y25.
The genetically modified organism (GMO) to be used in the clinical trial is ChAdOx1.HTI, a live, recombinant, chimpanzee adenovirus, with no capacity for replication due to deletions and genomic modifications.
In the ChAdOx1.HTI, the transgene that codes for the HTI insert has been inserted with the aim of inducing a specific T-cell HIV-1 immune response.


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