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Notification report


Full notification file


General information

Notification Number
B/ES/19/12

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
02/07/2019

Title of the Project
First-time-in human (FTIH), Phase I, randomized, multi-centric, single-blind, controlled dose-escalation study to evaluate the reactogenicity, safety immunogenicity and efficacy of GSK Biologicals’ HBV viral vectored vaccines given in a prime-boost schedule with sequential or co-administration of adjuvanted proteins therapeutic vaccine (GSK3528869A) in chronic Hepatitis B patients (18-65 years old) well controlled under nucleo(s)tides analogues (NA) therapy

Proposed period of release:
01/01/2020 to 30/06/2024

Name of the Institute(s) or Company(ies)
GlaxoSmithKline Biologicals, Rue de l’Institut, 89
1330 Rixensart, Belgium;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; France; United Kingdom;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
GMO ChAd155-hIi-HBV

Order: Adenoviridae
Ggenus: Mastadenovirus
Species: Simian adenovirus
Subspecies: Subgroup C
Strain: Serotype 155
Common name: ChAd155

The GMO ChAd155-hIi-HBV is a viral suspension of a recombinant replication-defective simian (chimpanzee-derived) group C adenovirus serotype 155 (ChAd155) viral vector encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens.
The two HBV proteins are the truncated core nucleocapsid protein antigen (HBc) and the full-length small surface antigen (HBs), separated by the self-cleaving 2A region of the foot-and mouth disease virus, that allows processing of the HBc-HBs fusion into separate protein antigens. In addition, the N-terminal part of the gene encoding the HBc protein has been fused to the gene encoding the human Major Histocompatibility Complex (MHC) class II-associated invariant chain p35 isoform (hIi).

The ChAd155 viral vector backbone (recipient organism) is derived from a simian adenovirus serotype 155 (parental organism) that was isolated from a healthy young chimpanzee housed at the New Iberia Research Center facility (The University of Louisiana at Lafayette, Louisiana, USA). The viral genome of the parental isolate was then cloned in a plasmid vector and subsequently modified to carry the deletion of E1 and E4 regions and the insertion of E4orf6 derived from human adenovirus type 5 (Ad5).


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
ChAd155MastadenovirusSimian adenovirussubgroup CSerotype 155-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known