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Notification report


Full notification file


General information

Notification Number
B/ES/19/08

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
19/06/2019

Title of the Project
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals who Have Sex with Cis-gender Men and/or Transgender Individuals.

Proposed period of release:
01/09/2019 to 01/01/2023

Name of the Institute(s) or Company(ies)
Janssen Vaccines & Prevention B.V., Archimedesweg 4-6
2333CP Leiden, The Netherlands;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Ad26.Mos4.HIV consists of four replication incompetent adenovirus vectors Ad26.Mos1.Gag-Pol, Ad26.Mos2.Gag-Pol, Ad26.Mos1.Env, and Ad26.Mos2S.Env. The Ad26.Mos4.HIV vectors are derived from the human Adenovirus group D type 26 (genus Mastadenoviridae.).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Ad26MastadenovirusAdenovirus Group DN/AType 26N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known