Chronic Hepatitis BPhase 2NCT05343481
Efficacy of VTP-300 in Chronic Hepatitis B Infection
A Phase 2 study testing ChAdOx1-HBV, MVA-HBV and Nivolumab in people with Chronic Hepatitis B, run by Barinthus Biotherapeutics at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ChAdOx1-HBV, MVA-HBV and Nivolumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 21 Sep 2022to 13 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or females aged ≥18 to ≤65 years at screening (according to country/local regulations)
- BMI ≤35 kg/m2
- Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate
- If female, willing not to become pregnant up to 8 weeks after the last dose of study vaccine and up to 5 months after the last dose of nivolumab
- If female: Not pregnant or breast feeding and one of the following:
- Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in ≥1 year and without an alternative medical cause)
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- Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to study vaccine and 8 weeks after VTP-300 and 5 months after the last dose of nivolumab. Highly effective methods of contraception include one or more of the following:
- Male partner who is sterile (medically effective vasectomy) prior to the female participant's entry into the study and is the sole sexual partner for the female participant
- Combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable
- An intrauterine device
- Bilateral tubal occlusion
- Abstinence from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- Documented evidence of CHB infection (e.g., HBsAg positive ≥6 months with detectable HBsAg levels at screening; both HBeAg+ and HBeAg- allowed)
- Receipt of only either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate) or besifovir for at least 6 months before screening
- HBV-DNA viral load ≤ 1,000 IU/mL
- HBsAg levels > 10 and ≤ 4,000 IU/mL
Who cannot join
- Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness in the opinion of the investigator would affect the safety of the participant or the evaluation of the data or interfere with adherence to the study requirements
- Medical history that is thought to increase the participant's risk of reaction to a vaccine, including but not limited to capillary leak syndrome; transverse myelitis, Guillain Barré syndrome, thrombosis with thrombocytopenia syndrome (also termed vaccine-induced thrombotic thrombocytopenia); heparin-induced thrombocytopenia HCV RNA positive
- HIV antibody positive and active hepatitis C (antibody positive and then DNA positive)
- Co-infection with hepatitis D virus (HDV)
- Documented cirrhosis or advanced fibrosis indicated by a liver biopsy within 6 months prior to Day 0 (Metavir activity grade A4 and stage F4; Ishak stages 5 - 6).
- In the absence of a documented liver biopsy, either 1 of the following (not both):
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- Screening Fibroscan with a result >9 kilopascals (kPa) (or the equivalent) within ≤ 6 months of screening, OR
- Both screening FibroTest >0.48 and aspartate aminotransferase (AST) to platelet ratio index (APRI) of >1.
- ALT >3 x ULN, or INR >1.5 unless the participant was stable on an anticoagulant regimen affecting INR, albumin <3.2 g/dL, direct bilirubin >1.5 x ULN, platelet count <100,000/µL.
- A history of liver decompensation (e.g., ascites, encephalopathy or variceal haemorrhage)
- Prior hepatocellular carcinoma
- Chronic liver disease of a non-HBV aetiology. (Note that Gilbert's syndrome, asymptomatic gallstones and non-alcoholic fatty liver not associated with steatohepatitis are not exclusions)
- History or evidence of autoimmune disease or known immunodeficiency of any cause except history of autoimmune thyroiditis if the participant is stable on replacement therapy
- Evidence of interstitial lung disease, active pneumonitis, myocarditis or a history of myocarditis
- Prolonged therapy with immunomodulators (e.g., corticosteroids such as prednisone >10 mg/day) or biologics (e.g., monoclonal antibodies, IFN) within 3 months of Day 1. Inhaled, intra-articular, intra-bursal or topical corticosteroids are allowed. Physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed.
- Receipt of immunoglobulin or other blood products within 3 months prior to Day 1
- Receipt of any investigational drug or vaccine within 3 months prior to Day 1
- Receipt of any non-oral adenoviral-based vaccine within 3 months prior to administration of ChAdOx1-HBV on Day 1
- Severe reaction to any vaccine, requiring medical attention
- Receipt of any live vaccines within 30 days prior to Day 1
- Receipt of any inactivated non-live vaccines (e.g., mRNA, inactivated vaccines, toxoid vaccines) within 14 days prior to Day 1
- History of severe hypersensitivity or anaphylactic reactions likely to be exacerbated by any component of VTP-300 or nivolumab, including severe allergy to egg
- Malignancy within 5 years prior to screening with the exception of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. Participants under evaluation for possible malignancy are not eligible
- Current alcohol or substance abuse judged by the investigator to potentially interfere with participant safety or compliance
- Any laboratory test which is abnormal, and which is deemed by the investigator to be clinically significant
- Any other finding that, in the opinion of the investigator, deems the participant unsuitable for the study
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Taiwan8 sites
Chia-Yi Christian Hospital
Chiayi City, Taiwan, 60002
Dalin Tzu Chi Hospital
Chiayi City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City
China Medical University Hospital
Taichung, Taiwan, 404332
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 333
Thailand8 sites
Chulabhorn Hospital
Bangkok, Thailand, 10210
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
HIV Netherlands-Australia-Thailand Research Collaboration
Bangkok, Thailand
Hospital For Tropical Diseases
Bangkok
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Research Institute For Health Sciences
Chiang Mai
Srinagarind Hospital
Khon Kaen
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand, 11000
Hong Kong2 sites
Prince Of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
About this study
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
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.
Read the detailed description
This is a multi-centre study conducted in 120 participants. All treatment groups will receive ChAdOx1-HBV on Day 1 and MVA-HBV on Day 29, and MVA boosts and nivolumab infusions as per treatment group as follows: Group 1: ChAdOx1-HBV, MVA-HBV and low dose nivolumab. Group 2: ChAdOx1-HBV, MVA HBV + low dose nivolumab, MVA HBV and low dose nivolumab. Group 3: ChAdOx1-HBV, MVA HBV, low dose nivolumab , MVA HBV. All participants return 7 days after each treatment (both immunotherapeutic and nivolumab infusion) visit to have chemistry and haematology safety laboratory studies obtained.
Participants are randomised to treatment in a 1:1:1 allocation. The primary objective of the study is to assess the efficacy of VTP-300 in combination with low-dose nivolumab in well-controlled CHB infection. The secondary objective of the study is to determine the safety and reactogenicity of the treatment regimens; this will be assessed by analysis of the incidence and severity of (serious) adverse events and any changes in laboratory values and vital signs. To assess the effect of VTP-300 in combination with low-dose nivolumab on the clearance of HBsAg and the impact of multiple booster doses of MVA-HBV and assess the appropriate timing of the use of low-dose nivolumab when used in combination with VTP-300.
Participants remain in the study for 12 months and attend clinic visits for treatment and assessments on Days 1, 8, 29, 36, 57, 85, 92, 113, 169, 252 and 336 (per Group allocation).
- Conditions
- Chronic Hepatitis B
- Being tested
- ChAdOx1-HBV, MVA-HBV, Nivolumab
- Keywords
- HBV, Chronic Hep B
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1-HBVBiological
Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus immunotherapeutic
MVA-HBVBiological
Modified Vaccinia Ankara-vectored Hepatitis B virus immunotherapeutic
NivolumabBiological
Also called Opdivo 10mg/ml concentrate for solution for infusion
Human immunoglobulin G4 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group 1 ChAdOx1-HBV, MVA-HBV and nivolumab | Experimental | 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 Receives: Biological: ChAdOx1-HBV; Biological: MVA-HBV; Biological: Nivolumab |
| Experimental: Group 2 ChAdOx1-HBV, MVA-HBV and nivolumab, MVA-HBV and nivolumab | Experimental | 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 Receives: Biological: ChAdOx1-HBV; Biological: MVA-HBV; Biological: Nivolumab |
| Experimental: Group 3 ChAdOx1-HBV, MVA-HBV, nivolumab, MVA-HBV | Experimental | 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 Receives: Biological: ChAdOx1-HBV; Biological: MVA-HBV; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of participants with a greater than 1 log HBsAg
Percentage of participants with a greater than 1 log HBsAg reduction at 6 months after initiation of therapy
Measured: 6 months after the initiation of therapy
Secondary outcomes (11)
The incidence of participants with Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 related adverse events following study treatment
The incidence of TEAEs and and ≥Grade 3 related adverse events will be based on the number and percentage of participants with events and number of events.
TEAEs are defined as all adverse events occurring after study IMP administration; they will be further categorised by Seriousness, Severity (i.e. ≥ Grade 3) and Causality.
Measured: 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
The incidence of TEAEs and ≥Grade 3 related adverse events will be based on the number and percentage of participants with events and number of events.
TEAEs are defined as all adverse events occurring after study IMP administration with nivolumab; they are further categorised by Seriousness, Severity (i.e. ≥ Grade 3) according to FDA Guidance 70 FR 22664 and Causality.
Measured: From each study administration with nivolumab for the following 7days
The incidence of participants with Adverse Events of Special Interest (AESIs)
AESIs specific to this study include pneumonitis, grade 3 or 4 diarrhoea, diabetes, thyroid diseases, colitis, nephritis, immune-related endocrinopathies, myocarditis, immune-related skin conditions, or other unspecified immune-related adverse reactions
Measured: From study admission (the signature of informed consent) to the end of the study (Month 12)
The incidence of participants with Treatment-Emergent Adverse Events (TEAEs) within each study group
The incidence of TEAEs will be based on the number and proportion of participants with events and number of events and will be calculated for each of the three study groups
Measured: From each study administration for the following 7 days
Incidence of participants with potentially clinically significant laboratory signs within each treatment group as assessed by the Investigator
The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant laboratory signs (haematology and biochemistry, including liver function tests) as assessed by the investigator.
All laboratory signs will be reported in SI units. If any laboratory sign is considered to be clinically significant i.e. outside laboratory normal reference range, the severity of this sign will be assessed according to the FDA Guidance for Industry 70 FR 22664. Absolute change, change from baseline and worst change for each participant will be calculated.
The incidence of participants with treatment-emergent, clinically significant laboratory signs and laboratory signs of Grade 3-4 severity will be calculated for each treatment group at each time point
Measured: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Incidence of participants with potentially clinically significant vital signs within each treatment group as assessed by the Investigator
The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant vital signs.
Vital signs will be considered to be potentially clinically significant if they respectively fall below or above the relevant upper and lower limits.
The incidence of participants with treatment-emergent, clinically significant vital signs will be calculated for each treatment group at each time point.
Measured: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Number of participants with worst changes from baseline in laboratory hematology parameters
Hematology laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA).
For all hematology parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study.
The number of participants showing shifts of at least two severity grades (as worst change from baseline for each hematology parameter) will be presented within shift tables.
Measured: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Number of participants with worst changes from baseline in laboratory biochemistry parameters
Biochemistry laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA).
For all biochemistry parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study.
The number of participants showing shifts of at least two severity grades (as worst change from baseline for each biochemistry parameter) will be presented within shift tables.
Measured: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Number of participants with worst changes from baseline in laboratory urinalysis parameters
Urinalysis laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA).
For all urinalysis parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study.
The number of participants showing shifts of at least two severity grades (as worst change from baseline for each urinalysis parameter) will be presented within shift tables.
Measured: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Number of participants with worst changes from baseline in vital signs parameters (heart rate, systolic blood pressure, diastolic blood pressure and temperature)
Worst change is defined as the lowest and highest post-baseline values for heart rate (bradycardia, tachycardia) and systolic blood pressure (hypotension, hypertension), and as the highest post-baseline values for diastolic blood pressure (hypertension) and temperature (fever).
For all vital signs' measurements, changes from baseline will be calculated for each timepoint at which the vital sign measurement is conducted throughout the study. The number of participants showing worst change from baseline for the vital signs parameters overall will be presented within shift tables.
Measured: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
T cell response to the HBV antigen inserts of VTP-300 as measured by interferon (IFN)-γ enzyme-linked immunospot (ELISpot)
This will be determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses (defined by number of peptide pools or individual peptides recognised). These data may be used to build immunologic models of the immune system.
Measured: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start21 Sep 2022
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants are randomised to the three treatment groups. Allocation to the groups is 1:1:1 allocation.
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barinthus Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343481
- Sponsor's protocol ID
- HBV-003
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05343481
- Acronym / sponsor ID
- HBV-003
- Conditions
- Chronic Hepatitis B
- Keywords
- HBV, Chronic Hep B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Barinthus BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-centre study conducted in 120 participants. All treatment groups will receive ChAdOx1-HBV on Day 1 and MVA-HBV on Day 29, and MVA boosts and nivolumab infusions as per treatment group as follows: Group 1: ChAdOx1-HBV, MVA-HBV and low dose nivolumab. Group 2: ChAdOx1-HBV, MVA HBV + low dose nivolumab, MVA HBV and low dose nivolumab. Group 3: ChAdOx1-HBV, MVA HBV, low dose nivolumab , MVA HBV. All participants return 7 days after each treatment (both immunotherapeutic and nivolumab infusion) visit to have chemistry and haematology safety laboratory studies obtained.
Participants are randomised to treatment in a 1:1:1 allocation. The primary objective of the study is to assess the efficacy of VTP-300 in combination with low-dose nivolumab in well-controlled CHB infection. The secondary objective of the study is to determine the safety and reactogenicity of the treatment regimens; this will be assessed by analysis of the incidence and severity of (serious) adverse events and any changes in laboratory values and vital signs. To assess the effect of VTP-300 in combination with low-dose nivolumab on the clearance of HBsAg and the impact of multiple booster doses of MVA-HBV and assess the appropriate timing of the use of low-dose nivolumab when used in combination with VTP-300.
Participants remain in the study for 12 months and attend clinic visits for treatment and assessments on Days 1, 8, 29, 36, 57, 85, 92, 113, 169, 252 and 336 (per Group allocation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomised to the three treatment groups. Allocation to the groups is 1:1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group 1 ChAdOx1-HBV, MVA-HBV and nivolumab | Experimental | Biological: ChAdOx1-HBV, Biological: MVA-HBV, Biological: NivolumabDay 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 nivolumab | Experimental | Biological: ChAdOx1-HBV, Biological: MVA-HBV, Biological: NivolumabDay 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-HBV | Experimental | Biological: ChAdOx1-HBV, Biological: MVA-HBV, Biological: NivolumabDay 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adult males or females aged ≥18 to ≤65 years at screening (according to country/local regulations)
- BMI ≤35 kg/m2
- Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate
- If female, willing not to become pregnant up to 8 weeks after the last dose of study vaccine and up to 5 months after the last dose of nivolumab
- If female: Not pregnant or breast feeding and one of the following:
Key exclusion criteria (26 listed)
- Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness in the opinion of the investigator would affect the safety of the participant or the evaluation of the data or interfere with adherence to the study requirements
- Medical history that is thought to increase the participant's risk of reaction to a vaccine, including but not limited to capillary leak syndrome; transverse myelitis, Guillain Barré syndrome, thrombosis with thrombocytopenia syndrome (also termed vaccine-induced thrombotic thrombocytopenia); heparin-induced thrombocytopenia HCV RNA positive
- HIV antibody positive and active hepatitis C (antibody positive and then DNA positive)
- Co-infection with hepatitis D virus (HDV)
- Documented cirrhosis or advanced fibrosis indicated by a liver biopsy within 6 months prior to Day 0 (Metavir activity grade A4 and stage F4; Ishak stages 5 - 6).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChAdOx1-HBVChimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus immunotherapeutic | Biological | Experimental: Group 1 ChAdOx1-HBV, MVA-HBV and nivolumab, Experimental: Group 2 ChAdOx1-HBV, MVA-HBV and nivolumab, MVA-HBV and nivolumab, Experimental: Group 3 ChAdOx1-HBV, MVA-HBV, nivolumab, MVA-HBV |
| MVA-HBVModified Vaccinia Ankara-vectored Hepatitis B virus immunotherapeutic | Biological | Experimental: Group 1 ChAdOx1-HBV, MVA-HBV and nivolumab, Experimental: Group 2 ChAdOx1-HBV, MVA-HBV and nivolumab, MVA-HBV and nivolumab, Experimental: Group 3 ChAdOx1-HBV, MVA-HBV, nivolumab, MVA-HBV |
| NivolumabAlso: Opdivo 10mg/ml concentrate for solution for infusionHuman immunoglobulin G4 monoclonal antibody | Biological | Experimental: Group 1 ChAdOx1-HBV, MVA-HBV and nivolumab, Experimental: Group 2 ChAdOx1-HBV, MVA-HBV and nivolumab, MVA-HBV and nivolumab, Experimental: Group 3 ChAdOx1-HBV, MVA-HBV, nivolumab, MVA-HBV |
Primary outcome
The incidence of participants with a greater than 1 log HBsAg
Time frame: 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
11 secondary outcomes
The incidence of participants with Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 related adverse events following study treatment
Time frame: 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
Time frame: From each study administration with nivolumab for the following 7days
The incidence of participants with Adverse Events of Special Interest (AESIs)
Time frame: From study admission (the signature of informed consent) to the end of the study (Month 12)
The incidence of participants with Treatment-Emergent Adverse Events (TEAEs) within each study group
Time frame: From each study administration for the following 7 days
Incidence of participants with potentially clinically significant laboratory signs within each treatment group as assessed by the Investigator
Time frame: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Incidence of participants with potentially clinically significant vital signs within each treatment group as assessed by the Investigator
Time frame: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Number of participants with worst changes from baseline in laboratory hematology parameters
Time frame: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Number of participants with worst changes from baseline in laboratory biochemistry parameters
Time frame: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Number of participants with worst changes from baseline in laboratory urinalysis parameters
Time frame: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Number of participants with worst changes from baseline in vital signs parameters (heart rate, systolic blood pressure, diastolic blood pressure and temperature)
Time frame: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
T cell response to the HBV antigen inserts of VTP-300 as measured by interferon (IFN)-γ enzyme-linked immunospot (ELISpot)
Time frame: Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ChAdOx1-HBV, MVA-HBV and Nivolumab in people with Chronic Hepatitis B, run by Barinthus Biotherapeutics at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Taiwan, Thailand, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of participants with a greater than 1 log HBsAg (time frame: 6 months after the initiation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.