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 I, randomized, double-blind, placebo-controlled safety, tolerability and immunogenicity study of candidate HIV-1 vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI in early treated HIV-1 positive individuals (AELIX-002).

Proposed period of release:
01/02/2019 to 31/07/2020

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?
Belgium; Denmark; Spain; France;

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

If yes, notification number(s):
B/ES/16/11; B/ES/18/21;

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
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-Modified vaccinia virus Ankara-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known