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
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?
Belgium; Germany; France; United Kingdom;

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

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