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ChAdOx1-HBV

Phase 2

Chronic Hepatitis B | Monoclonal antibody | Infectious Disease |Barinthus Biotherapeutics plc|Last Updated: Apr 30, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment121
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05343481Efficacy of VTP-300 in Chronic Hepatitis B InfectionPHASE2 COMPLETED 121 — — Sep 21, 2022Jan 13, 2026Apr 30, 202618 Hong Kong, Taiwan +1
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Study Endpoints
Primary Endpoints
The incidence of participants with a greater than 1 log HBsAg
6 months after the initiation of therapy

Percentage of participants with a greater than 1 log HBsAg reduction at 6 months after initiation of therapy

Secondary Endpoints
The incidence of participants with Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 related adverse events following study treatment
From each study vaccination for the following 7 days
The incidence of participants with Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 related adverse events following administration with nivolumab
From each study administration with nivolumab for the following 7days
The incidence of participants with Adverse Events of Special Interest (AESIs)
From study admission (the signature of informed consent) to the end of the study (Month 12)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental: Group 1 ChAdOx1-HBV, MVA-HBV and nivolumabEXPERIMENTALDay 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: Group 2 ChAdOx1-HBV, MVA-HBV and nivolumab, MVA-HBV and nivolumabEXPERIMENTALDay 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: Group 3 ChAdOx1-HBV, MVA-HBV, nivolumab, MVA-HBVEXPERIMENTALDay 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
Interventions
NameTypeDescription
ChAdOx1-HBVBIOLOGICALChimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus immunotherapeutic
MVA-HBVBIOLOGICALModified Vaccinia Ankara-vectored Hepatitis B virus immunotherapeutic
NivolumabBIOLOGICALHuman immunoglobulin G4 monoclonal antibody
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: 1. Adult males or females aged ≥18 to ≤65 years at screening (according to country/local regulations) 2. BMI ≤35 kg/m2 3. Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate 4. If femal...

Countries:Hong KongTaiwanThailand
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Recent Changes (Last 90 Days)
MEDIUMMay 31, 2026NCT05343481TRIAL_REMOVED: changed
MEDIUMMay 31, 2026NCT05343481TRIAL_REMOVED: changed
MEDIUMMay 31, 2026NCT05343481TRIAL_REMOVED: changed
HIGHMay 26, 2026NCT05343481Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT05343481studyFirstPostDate: changed