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Notification report


Full notification file


General information

Notification Number
B/DE/18/PEI3392

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
16/04/2018

Title of the Project
A 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.

EudraCT number of the study is: 2017-001452-55 and the Applicant’s study code is: 204852 (abbreviated title: TH HBV VV-001).


Proposed period of release:
01/07/2018 to 31/03/2021

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


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; 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:
(i) order: Adenoviridae
(ii) genus: Mastadenovirus
(iii) species: Simian adenovirus
(iv) subspecies: Subgroup C
(v) strain: Serotype 155
(vi) pathovar: …
(vii) 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 Adenovirus Subgroup Csubgroup Cserotype 155N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
26/11/2018 00:00:00
Remarks: