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ACTIVE NOT RECRUITING
NCT05343481
PHASE2

Efficacy of VTP-300 in Chronic Hepatitis B Infection

Sponsor: Barinthus Biotherapeutics

View on ClinicalTrials.gov

Summary

This is an open-label study to determine the efficacy, safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV, together VTP-300, in combination with low-dose nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.

Official title: A Phase 2b, Open-label Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity and Treatment Regimens of VTP-300 Combined With Low-dose Nivolumab in Chronic Hepatitis B Infection

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-09-21

Completion Date

2026-10

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

ChAdOx1-HBV

Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus immunotherapeutic

BIOLOGICAL

MVA-HBV

Modified Vaccinia Ankara-vectored Hepatitis B virus immunotherapeutic

BIOLOGICAL

Nivolumab

Human immunoglobulin G4 monoclonal antibody

Locations (18)

Prince Of Wales Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Chia-Yi Christian Hospital

Chiayi City, Taiwan

Dalin Tzu Chi Hospital

Chiayi City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Chulabhorn Hospital

Bangkok, Thailand

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

HIV Netherlands-Australia-Thailand Research Collaboration

Bangkok, Thailand

Hospital For Tropical Diseases

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Research Institute For Health Sciences

Chiang Mai, Thailand

Srinagarind Hospital

Khon Kaen, Thailand

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Thailand