Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

March 28, 2019

Primary Completion Date

October 7, 2024

Study Completion Date

October 7, 2024

Conditions
Hepatitis B, Chronic
Interventions
BIOLOGICAL

ChAd155-hIi-HBV low dose formulation

Subjects in group A1 receive one dose of ChAd155-hIi-HBV low dose formulation at Day 1, by intramuscular injection in the deltoid of the non-dominant arm.

BIOLOGICAL

ChAd155-hIi-HBV high dose formulation

"Subjects in groups B1 and B3 receive one dose of ChAd155-hIi-HBV high dose formulation at Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the non-dominant arm.~Subjects in groups C1 and C2 receive one dose of ChAd155-hIi-HBV high dose formulation at Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the dominant arm."

BIOLOGICAL

HBc-HBs/AS01B-4 low dose formulation

Subjects in group A1 receive two doses of HBc-HBs/AS01B-4 low dose formulation, one at Day 113 and one at Day 169 and subjects in group A2 receive four doses of the low dose formulation, one dose each at Days 1, 57, 113 and 169, by intramuscular injection in the deltoid of the non-dominant arm.

BIOLOGICAL

HBc-HBs/AS01B-4 high dose formulation

Subjects in group B1 receive two doses of HBc-HBs/AS01B-4 high dose formulation, one at Day 113 and one at 169; subjects in group B2 receive four doses, one dose each at Days 1, 57, 113 and 169; subjects in group C1 receive four co-administered doses at Days 1, 57, 113 and 169 and subjects in group C2 receive two co-administered doses at Days 113 and 169, by intramuscular injection in the deltoid of the non-dominant arm.

BIOLOGICAL

MVA-HBV low dose formulation

Subjects in group A1 receive one dose of MVA-HBV low dose formulation at Day 57, by intramuscular injection in the deltoid of the non-dominant arm.

BIOLOGICAL

MVA-HBV high dose formulation

"Subjects in groups B1 and B3 receive one dose of MVA-HBV high dose formulation at Day 57 and Day 169 respectively, by intramuscular injection in the deltoid of the non-dominant arm.~Subjects in group C1 receive three co-administered doses of the vaccine at Days 57, 113 and 169 and subjects in group C2 receive one co-administered dose of the vaccine at Day 169, by intramuscular injection in the deltoid of the dominant arm."

DRUG

Placebo

Subjects in group A3 receive four doses of placebo, one each at Days 1, 57, 113 and 169 and subjects in group B3 receive two doses of placebo one each at Days 1 and 57, by intramuscular injection in the deltoid of the non-dominant arm. Subjects in group C2 receive 2 co-administered doses of placebo at Days 1 and 57, by intramuscular injection in the deltoid of the dominant and non-dominant arm.

Trial Locations (43)

112

GSK Investigational Site, Taipei

333

GSK Investigational Site, Taoyuan District

704

GSK Investigational Site, Tainan City

1070

GSK Investigational Site, Brussels

2650

GSK Investigational Site, Antwerp

GSK Investigational Site, Edegem

9000

GSK Investigational Site, Ghent

10330

GSK Investigational Site, Bangkok

10787

GSK Investigational Site, Berlin

14004

GSK Investigational Site, Córdoba

18016

GSK Investigational Site, Granada

20246

GSK Investigational Site, Hamburg

28006

GSK Investigational Site, Madrid

28007

GSK Investigational Site, Madrid

28034

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Madrid

28850

GSK Investigational Site, TorrejOn Ardoz Madrid

39008

GSK Investigational Site, Santander

40447

GSK Investigational Site, Taichung

40705

GSK Investigational Site, Taichung

41013

GSK Investigational Site, Seville

45122

GSK Investigational Site, Essen

50200

GSK Investigational Site, Chiang Mai

52074

GSK Investigational Site, Aachen

53127

GSK Investigational Site, Bonn

55131

GSK Investigational Site, Mainz

60590

GSK Investigational Site, Frankfurt

67091

GSK Investigational Site, Strasbourg

69317

GSK Investigational Site, Lyon

72076

GSK Investigational Site, Tübingen

92118

GSK Investigational Site, Clichy

94010

GSK Investigational Site, Créteil

Unknown

GSK Investigational Site, Pokfulam

31-202

GSK Investigational Site, Krakow

41-400

GSK Investigational Site, Mysłowice

60-185

GSK Investigational Site, Poznan

37-100

GSK Investigational Site, Łańcut

08011

GSK Investigational Site, Barcelona

08907

GSK Investigational Site, Barcelona

07120

GSK Investigational Site, Palma de Mallorca

E1 1BB

GSK Investigational Site, London

SW17 0QT

GSK Investigational Site, London

NG7 2UH

GSK Investigational Site, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03866187 - Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection | Biotech Hunter | Biotech Hunter