First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBV
NCT04778904 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2024-08-13
Summary
This is an open-label study to determine the safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV vaccines, with or without nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.
Conditions
Interventions
- BIOLOGICAL
-
ChAdOx1-HBV
Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
- BIOLOGICAL
-
MVA-HBV
Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
- BIOLOGICAL
-
Human immunoglobulin G4 monoclonal antibody
Sponsors & Collaborators
-
Barinthus Biotherapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-22
- Primary Completion
- 2023-02-24
- Completion
- 2023-02-24
Countries
- South Korea
- Taiwan
- United Kingdom
Study Locations
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