Back

Notification report


Full notification file


General information

Notification Number
B/BE/18/BVW4

Member State to which the notification was sent
Belgium

Date of acknowledgement from the Member State Competent Authority
19/07/2018

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

Proposed period of release:
01/07/2018 to 30/03/2023

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:
Identity of the GMO: ChAd155-hIi-HBV
(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 footand-
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 Iiassociated
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).

MVA-HBV:
Identity of the GMO: Modified Vaccinia Virus Ankara (MVA)
Genus: Orthopoxvirus
Species: Vaccinia Virus
The GMO is a modified vaccinia virus Ankara vector (MVA) 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. The 2A
region allows processing of the HBc-2A-HBs transcript into the expression of two separate
HBc and HBs protein antigens.
MVA is a highly attenuated vaccinia virus strain that was developed by repeated passaging
(> 570 passages) of the chorioallantois vaccinia virus Ankara (CVA) in primary cell culture
of chicken embryo fibroblasts (Mayr et al. 1978). The resulting MVA strain was used during
the smallpox eradication campaign to vaccinate over 120,000 people considered at high risk
of adverse events for the vaccinia vaccine (Stickl et al. 1974). While the vaccinia virus
exhibits a wide host range, is able to efficiently replicate in human cells, and has caused
laboratory-acquired vaccinia vius infections (Isaacs et al. 2012). In contrast, MVA exhibits a
narrow host range and is not able to replicate in human cells. For the reasons, the vaccinia
virus is classified as a risk group 2 biological agent, whereas the MVA strain is risk group 1
(Stellberger et al. 2016).


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
ChAd155MastadenovirusSimian Adenovirus Subgroup Csubgroup Cserotype 155-
MVA. Bovis Bacille Calmette-Guerinorthopoxvirusvaccinia virus-Modified vaccinia virus Ankara-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known