Efficacy of VTP-300 in Chronic Hepatitis B Infection

Sponsor
Barinthus Biotherapeutics
Study ID
NCT05343481
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Hepatitis B

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ChAdOx1-HBV — BIOLOGICAL
    Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus immunotherapeutic
  • MVA-HBV — BIOLOGICAL
    Modified Vaccinia Ankara-vectored Hepatitis B virus immunotherapeutic
  • Nivolumab — BIOLOGICAL
    Human immunoglobulin G4 monoclonal antibody

Study Details

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.

Key Dates

Start date
Sep 21, 2022
Status verified
Apr 2026
Primary completion
Jan 13, 2026
Completion
Jan 13, 2026

Study Design

Enrollment
121 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Group 1 ChAdOx1-HBV, MVA-HBV and nivolumab
    Day 1: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 29: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
  • Experimental: Experimental: Group 2 ChAdOx1-HBV, MVA-HBV and nivolumab, MVA-HBV and nivolumab
    Day 1: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 29: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion Day 85: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
  • Experimental: Experimental: Group 3 ChAdOx1-HBV, MVA-HBV, nivolumab, MVA-HBV
    Day 1: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 29: MVA-HBV 1 x 10\^8 pfu IM injection Day 36: Nivolumab 0.3 mg/kg IV infusion Day 85: MVA-HBV 1 x 10\^8 pfu IM injection

Primary Outcome Measure

The incidence of participants with a greater than 1 log HBsAg [ Time Frame: 6 months after the initiation of therapy ]

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