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 ChAdOx1.HTI and MVA.HTI with Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted with MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals.

Proposed period of release:
01/09/2020 to 31/01/2022

Name of the Institute(s) or Company(ies)
Hospital Universitari Germans Trias i Pujol (HUGTP), Carretera de Canyet, s/n, 08916
Badalona (Barcelona, Spain);

3. Is the same GMO release planned elsewhere in the Community?

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

If yes, notification number(s):
B/ES/18/20; 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 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 HIV-1 specific T-cell 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