NCT03866187

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

A first-time-in Human (FTIH), Phase I/II, Randomized, Multi-centric, Single-blind, Controlled Dose-escalation Study to Evaluate the Reactogenicity, Safety, Immunogenicity and Efficacy of GSK Biologicals' HBV Viral Vector 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)Tide Analogue (NA) Therapy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed participants under nucleo(s)tide treatment.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	ChAd155-hIi-HBV low dose formulation	Participants in group A1 were scheduled to receive one dose of ChAd155-hIi-HBV low dose formulation on Day 1, by intramuscular injection in the deltoid of the non-dominant arm.
BIOLOGICAL	ChAd155-hIi-HBV high dose formulation	Participants in groups B1 and B3 were scheduled to receive one dose of ChAd155-hIi-HBV high dose formulation on Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the non-dominant arm. Participants in groups C1 and C2 were scheduled to receive one dose of ChAd155-hIi-HBV high dose formulation on Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the dominant arm.
BIOLOGICAL	HBc-HBs/AS01B-4 low dose formulation	Participants in group A1 were scheduled to receive two doses of HBc-HBs/AS01B-4 low dose formulation, one on Day 113 and one on Day 169, and participants in group A2 were scheduled to receive four doses of the HBc-HBs/AS01B-4 low dose formulation, one dose each on 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	Participants in group B1 were scheduled to receive two doses of HBc-HBs/AS01B-4 high dose formulation, one on Day 113 and one on Day 169; participants in group B2 were scheduled to receive four doses of HBc-HBs/AS01B-4 high dose formulation, one dose each on Days 1, 57, 113 and 169; participants in group C1 were scheduled to receive four co-administered doses of HBc-HBs/AS01B-4 high dose formulation on Days 1, 57, 113 and 169 and participants in group C2 were scheduled to receive two co-administered doses HBc-HBs/AS01B-4 high dose formulation on Days 113 and 169, by intramuscular injection in the deltoid of the non-dominant arm.
BIOLOGICAL	MVA-HBV low dose formulation	Participants in group A1 were scheduled to receive one dose of MVA-HBV low dose formulation on Day 57, by intramuscular injection in the deltoid of the non-dominant arm.
BIOLOGICAL	MVA-HBV high dose formulation	Participants in groups B1 and B3 were scheduled to receive one dose of MVA-HBV high dose formulation on Day 57 and Day 169 respectively, by intramuscular injection in the deltoid of the non-dominant arm. Participants in group C1 were scheduled to receive three co-administered doses of the MVA-HBV high dose formulation on Days 57, 113 and 169 and participants in group C2 were scheduled to receive one co-administered dose of the MVA-HBV high dose formulation on Day 169, by intramuscular injection in the deltoid of the dominant arm.
DRUG	Placebo	Participants in group A3 were scheduled to receive four doses of placebo, one each on Days 1, 57, 113 and 169 and participants in group B3 were scheduled to receive two doses of placebo one each on Days 1 and 57, by intramuscular injection in the deltoid of the non-dominant arm. Participants in group C2 were scheduled to receive two co-administered doses of placebo on Day 1 and two co-administered doses of placebo on Day 57, by intramuscular injection in the deltoid of the dominant and non-dominant arm.

Timeline

• Start date: 2019-03-28
• Primary completion: 2024-10-07
• Completion: 2024-10-07
• First posted: 2019-03-07
• Last updated: 2026-02-20
• Results posted: 2026-02-20

Locations

43 sites across 9 countries: Belgium, France, Germany, Hong Kong, Poland, Spain, Taiwan, Thailand, United Kingdom