First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBV

Sponsor
Barinthus Biotherapeutics
Study ID
NCT04778904
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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 vaccine
  • MVA-HBV — BIOLOGICAL
    Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
  • Nivolumab — BIOLOGICAL
    Human immunoglobulin G4 monoclonal antibody

Study Details

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.

Key Dates

Start date
Dec 22, 2020
Status verified
Aug 2024
Primary completion
Feb 24, 2023
Completion
Feb 24, 2023

Study Design

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

Arms

  • Experimental: Group 1 (MVA-HBV)
    Day 0: MVA-HBV 1 x 10\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
  • Experimental: Group 2 (ChAdOx1-HBV, MVA-HBV)
    Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection
  • Experimental: Group 3 (ChAdOx1-HBV, MVA-HBV and nivolumab)
    Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
  • Experimental: Group 4 (ChAdOx1-HBV and nivolumab, MVA-HBV and nivolumab)
    Day 0: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion

Primary Outcome Measure

The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination [ Time Frame: From each study vaccination for the following 27 days ]

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