Hepatitis BPhase 1NCT04297917
First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection
A Phase 1 study testing ChAdOx1-HBV in people with Hepatitis B and Healthy, run by Barinthus Biotherapeutics at 4 sites in United Kingdom.
Trial summary
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Healthy
- What is being tested?
- ChAdOx1-HBV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 10 Feb 2019to 26 Jun 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males or females aged ≥18 to ≤65 years at screening
- Body Mass Index ≤30 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 last dose of study vaccine, not breast feeding
- If female: Not pregnant, and one of the following:
- Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are post menopausal, as defined by no menses in ≥1 year)
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- Sexual abstinence, only if the participant refrains from heterosexual intercourse during the entire study period and it is the usual lifestyle of the participant
- Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to study vaccine and 8 weeks after study vaccine. 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, Hormonal (oral, intravaginal, transdermal, implantable or injectable), An intrauterine hormone releasing system, An intrauterine device and Bilateral tubal occlusion
- Healthy participants (cohorts 1 and 2):
- Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator
- Participants with well controlled CHB (cohorts 3 and 4):
- Documented evidence of chronic HBV infection (e.g. HBsAg positive ≥6 months with detectable HBsAg levels at screening)
- Receipt of only either entecavir or tenofovir for at least 12 months before screening
- Virally suppressed (HBV DNA <40 IU/mL for ≥6 months)
- HBsAg <4000IU/mL
- Participants with well controlled CHB (cohorts 3 and 4):
- 7. Documented evidence of chronic HBV infection (e.g. HBsAg positive ≥6 months with detectable HBsAg levels at screening) 8. Receipt of only either entecavir or tenofovir for at least 12 months before screening 9. Virally suppressed (HBV DNA <40 IU/mL for ≥6 months) 10. HBsAg <10000 IU/mL
- Healthy participants (cohort 5):
- 11. Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator 12. Adult males or females aged ≥40 to ≤60 years at screening 13. Completed second dose of COVID-19 AZD1222 vaccine 10 to 18 weeks before enrolment
- Healthy participants (cohort 6):
- 14. Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator
- 15. Adult males or females aged ≥40 to ≤60 years at screening
- 16. Received the latest dose of Completed of either Pfizer (Comirnaty®) or Moderna (Spikevax) mRNA COVID 19 vaccine 6 to 30 weeks before enrolment
Who cannot join
- Presence of any significant acute or chronic, uncontrolled medical/ psychiatric illness
- Hepatitis C virus antibody positive.
- Human immunodeficiency virus antibody positive
- History or evidence of autoimmune disease or known immunodeficiency of any cause
- Prolonged therapy with immunomodulators (e.g. corticosteroids) or biologics (e.g. monoclonal antibodies, interferon) within 3 months of screening
- Receipt of immunoglobulin or other blood products within 3 months prior to screening
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- Receipt of any investigational drug or vaccine within 3 months prior to screening
- Cohorts 1-4: Receipt of any adenoviral vaccine within 3 months prior to administration of ChAdOx1-HBV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0
- Cohorts 5 and 6: Receipt of any adenoviral vaccine (other than AZD1222 per inclusion criterion 13) within 3 months prior to administration of ChAdOx1-HBV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0
- Receipt of any live vaccines within 30 days prior to screening
- Receipt of any inactivated vaccines within 14 days prior to screening
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Any history of anaphylaxis in reaction to vaccination
- Malignancy within 5 years prior to screening with the exception of specific cancers that are cured by surgical resection (e.g. except basal cell skin carcinoma of the skin and cervical carcinoma). Participants under evaluation for possible malignancy are not eligible
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant safety and compliance
- Significant cardiac disease or unstable uncontrolled cardiac disease
- Any laboratory test at screening 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 Additionally, for healthy participants (cohorts 1, 2, 5 and 6)
- HBsAg positive Additionally, for participants with well controlled CHB (cohorts 3 and 4)
- Co infection with hepatitis delta
- Documented cirrhosis or advanced fibrosis indicated by a liver biopsy within 6 months prior to screening.
- In the absence of an appropriate liver biopsy, either 1 of the following:
- Screening Fibroscan with a result >9 kPa within ≤6 months of screening or
- Screening FibroTest >0.48 and aspartate aminotransferase (AST) to platelet ratio index of >1 In the event of discordant results between non-invasive methods, the Fibroscan result will take precedence.
- Alanine transaminase (ALT) >3 × upper limit of normal, international normalised ratio (INR) >1.5 unless the participant was stable on an anticoagulant regimen affecting INR, albumin <35 g/L, total bilirubin >2 mg/dL, platelet count <100,000/mL
- A history of liver decompensation (e.g. ascites, encephalopathy or variceal haemorrhage)
- Prior or current hepatocellular carcinoma
- Chronic liver disease of a non HBV aetiology
- Any herbal supplements and or other medicines with potential liver toxicity within the previous 3 months prior to enrolment into this study
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Headington, Oxford, OX3 7LE
Medicines Evaluations Unit
Manchester, M23 9QZ
Oxford University Hospitals Nhs Foundation Trust
Oxford, Oxfordshire, OX3 9DU
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: A Phase 1 Monotherapy Study to Evaluate the Safety, Tolerability & Immunogenicity of Vaccination With Candidate Chimpanzee Adenovirus-vectored HepB Virus Vaccine ChAdOx1 HBV in Healthy Participants & Participants With Chronic HepB Infection
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication. This will be an open-label, non randomised dose escalation study comparing the safety, tolerability and immunogenicity of 2 different doses of ChAdOx1 HBV vaccine. T cell responses in healthy participants who have received a prior two-dose series of AZD1222 will be compared with those who have received either the Pfizer COVID 19 vaccine or the Moderna mRNA COVID 19 vaccine.
Read the detailed description
This is a first in man human study of a therapeutic vaccine for chronic hepatitis B infection(ChAdOx1-1HBV). The vaccine was given to participants in a dose escalation strategy (two doses). Five healthy participants was administered the low dose first (cohort 1). Dose escalation was only initiated in the next 5 healthy participants (cohort 2) following Safety Monitoring Committee (SMC) review.
Six CHB participants was administered the low dose (cohort 3) before the dose escalation was initiated in the remaining 5 CHB participants (cohort 4).
Twenty-six healthy participants (15 who have received two doses of AZD1222 [cohort 5] and 11 who have received at least two prior doses of Pfizer/Moderna mRNA COVID 19 vaccine [cohort 6]) were dosed in parallel with the high dose used in cohorts 2 and 4.
Each participant received 1 dose of the vaccine (intramuscular injection). Participants (Volunteers \& patients) in cohorts 1 to 4 attended up to 9 study visits and cohorts 5 \& 6 attended up to 4 visits in total. The last visit was 24 weeks after vaccination for cohorts 1 to 4 and 12 weeks for cohorts 5 \& 6.
- Conditions
- Hepatitis B, Healthy
- Being tested
- ChAdOx1-HBV
- Medical subject headings
- 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-vectored hepatitis B virus vaccine
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers with low dose vaccination | Experimental | 5 Healthy Volunteers receiving low dose vaccination Receives: Biological: ChAdOx1-HBV |
| Healthy Volunteers with high dose vaccination | Experimental | 5 Healthy Volunteers receiving high dose vaccination Receives: Biological: ChAdOx1-HBV |
| Chronic Hepatitis B participants with low dose vaccination | Experimental | 6 participants with Chronic Hepatitis B infection receiving low dose vaccination Receives: Biological: ChAdOx1-HBV |
| Chronic Hepatitis B participants with high dose vaccination | Experimental | 5 participants with Chronic Hepatitis B infection receiving high dose vaccination Receives: Biological: ChAdOx1-HBV |
| Healthy Volunteers who have had COVID-19 AZD1222 vaccine | Experimental | 15 participants who have had 2 doses of COVID-19 AZD1222 vaccine receiving high dose vaccination. Receives: Biological: ChAdOx1-HBV |
| Healthy Volunteers who have had Pfizer/Moderna mRNA COVID 19 vaccine | Experimental | 11 participants who have had 2 doses of either Pfizer/Moderna mRNA COVID 19 vaccine receiving high dose vaccination Receives: Biological: ChAdOx1-HBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Safety and Reactogenicity Events: Adverse Events
Adverse events and/or adverse events leading to study discontinuation. Percentages are based on the number of participants in the Safety Analysis Set.
Measured: Recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months)
Incidence of Safety and Reactogenicity Events: Serious Adverse Events
Serious adverse events related to the study vaccine. Percentages are based on the number of participants in the Safety Analysis Set.
Measured: From day 0 to up to 6 months
Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions
Local reactions were collected by the investigator pre and post vaccination on Day 0. In addition, local reactions were captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised.
Measured: From day 0 to day 3
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Systemic reactions were collected by the investigator pre and post vaccination on Day 0 and captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised.
Measured: From day 0 to day 3
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
Intracellular cytokine staining analysis to measure IFNγ, produced by HBV antigen or hexon-specific CD8+ T cells in PBMC across study timepoints
Measured: Baseline, Day 14, 28, 56, 84
Secondary outcomes (11)
Reduction in HBsAg Titre Post-vaccination in CHB Participants
For the CHB participants only. HBsAg levels were measured at each scheduled follow-up timepoint (Day 28, Day 56, Day 84 and Day 168).
A summary of the change is obtained by summarising the difference in the log-transformed results [log(HbsAg at baseline + 1) - log(HbsAg at follow-up + 1)] and back-transforming to absolute values (IU/mL). The mean change is then the Geometric Mean (GM) ratio, where a GM ratio > 1 is equivalent to a reduction in HbsAg.
Measured: Baseline, Day 28, 56, 84 and 168
Loss of Both HBeAg and HBsAg
For the CHB participants only, loss of HBeAg and HBsAg at the End of Study assessment (Day 168) include all CHB participants in the denominator. Numerators include participants with a) detectable HBeAg and HBsAg at the Day 0 pre-dose assessment and b) undetectable HBeAg and HBsAg at the End of Study assessment.
Measured: Baseline and Day 168
Proportion of CHB Participants With HBeAg and HBsAg Seroconversion
The seroconversion of HBeAg and HBsAg is defined as loss of response to the antigen (defined as a value below the limit of detection (i.e. Not detected) and development of antibody to either HBeAg or surface antigen (HBsAg) (defined as a measurable value above the limit of detection (i.e. Detected). The number and percentage of CHB participants meeting the criteria for seroconversion will be summarised.
Measured: Baseline, Day 28, 56, 84 and 168
Reduction of Hepatitis B DNA Levels in CHB Participants
Change in hepatitis B DNA levels is defined by subtracting the DNA levels at each follow-up visit (Day 28, Day 56, Day 84 and Day 168) from the DNA levels pre-vaccination (Day 0). A positive change is equivalent to a reduction in DNA levels. Any results recorded as Not Detected were replaced with zero prior to summarising while any recorded as Detected or 1 (the limit of detection) were replaced with 0.5, prior to summarising. The denominator is the number of participants in the analysis set.
Measured: Baseline, Day 28, 56, 84 and 168
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD4+ and CD8+ cells were analyzed at selected baseline and follow up study visits (Day 0, Day 14, Day 28, Day 56, and/or Day 84) using intracellular cytokine staining (ICS) data from a flow cytometer. Outcome 'A Multiparameter Index Made of CD4+Magnitude, CD4+ Avidity and CD8+ Magnitude' was not calculated.
Measured: Baseline, 14, 28, 56, and 84
Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values < 25 with zero prior to summarising.
Measured: Baseline, Day 14, 28, 56, 84 and 168
Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values < 25 with zero prior to summarising.
Measured: Baseline, Day 14, 28, 56, 84 and 168
Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values < 25 with zero prior to summarising.
Measured: Baseline, Day 14, 28, 56, 84 and 168
Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values < 25 with zero prior to summarising.
Measured: Baseline, Day 14, 28, 56, 84 and 168
Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
Intracellular cytokine staining analysis to measure IFNγ, produced by hexon-specific CD4+ T cells in PBMC across study timepoints
Measured: Baseline, Day 14, 28, 84
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
Intracellular cytokine staining analysis to measure IFNγ, produced by hexon-specific CD8+ T cells in PBMC across study timepoints
Measured: Baseline, Day 14, 28, 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start10 Feb 2019
- Primary completion23 May 2022
- Study completion26 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The participants were recruited in 6 cohorts as follows - Cohort 1 - Healthy Volunteers - Low dose Vaccine - 5 participants Cohort 2 - Healthy Volunteers - High dose Vaccine - 5 participants Cohort 3 - Participants with Chronic Hepatitis B infection - Low dose - 6 participants Cohort 4 - Participants with Chronic Hepatitis B infection - High dose - 5 participants Cohort 5 - Healthy Volunteers who have completed 2 doses of COVID-19 AZD1222 vaccine Cohort 6 - Healthy Volunteers who have completed 2 doses of either Pfizer or Moderna mRNA COVID 19 vaccine
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barinthus Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eleanor Barnes, Prof, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297917
- Sponsor's protocol ID
- HBV001
- Status last verified
- Jul 2025
- First submitted
- 28 Feb 2020
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cargill T, Cicconi P, Brown A, Holland L, Karanth B, Rutkowski K, Ashwin E, Mehta R, Chinnakannan S, Sebastian S, Bussey L, Sorensen H, Klenerman P, Evans T, Barnes E. HBV001: Phase I study evaluating the safety and immunogenicity of the therapeutic vaccine ChAdOx1-HBV. JHEP Rep. 2023 Aug 18;5(11):100885. doi: 10.1016/j.jhepr.2023.100885. eCollection 2023 Nov.
PubMed 37791379
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Monotherapy Study to Evaluate the Safety, Tolerability & Immunogenicity of Vaccination With Candidate Chimpanzee Adenovirus-vectored HepB Virus Vaccine ChAdOx1 HBV in Healthy Participants & Participants With Chronic HepB Infection
- ClinicalTrials.gov ID
- NCT04297917
- Acronym / sponsor ID
- HBV001
- Conditions
- Hepatitis B, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Barinthus BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 26 Jun 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication. This will be an open-label, non randomised dose escalation study comparing the safety, tolerability and immunogenicity of 2 different doses of ChAdOx1 HBV vaccine. T cell responses in healthy participants who have received a prior two-dose series of AZD1222 will be compared with those who have received either the Pfizer COVID 19 vaccine or the Moderna mRNA COVID 19 vaccine.
Detailed description
This is a first in man human study of a therapeutic vaccine for chronic hepatitis B infection(ChAdOx1-1HBV). The vaccine was given to participants in a dose escalation strategy (two doses). Five healthy participants was administered the low dose first (cohort 1). Dose escalation was only initiated in the next 5 healthy participants (cohort 2) following Safety Monitoring Committee (SMC) review.
Six CHB participants was administered the low dose (cohort 3) before the dose escalation was initiated in the remaining 5 CHB participants (cohort 4).
Twenty-six healthy participants (15 who have received two doses of AZD1222 [cohort 5] and 11 who have received at least two prior doses of Pfizer/Moderna mRNA COVID 19 vaccine [cohort 6]) were dosed in parallel with the high dose used in cohorts 2 and 4.
Each participant received 1 dose of the vaccine (intramuscular injection). Participants (Volunteers \& patients) in cohorts 1 to 4 attended up to 9 study visits and cohorts 5 \& 6 attended up to 4 visits in total. The last visit was 24 weeks after vaccination for cohorts 1 to 4 and 12 weeks for cohorts 5 \& 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- The participants were recruited in 6 cohorts as follows - Cohort 1 - Healthy Volunteers - Low dose Vaccine - 5 participants Cohort 2 - Healthy Volunteers - High dose Vaccine - 5 participants Cohort 3 - Participants with Chronic Hepatitis B infection - Low dose - 6 participants Cohort 4 - Participants with Chronic Hepatitis B infection - High dose - 5 participants Cohort 5 - Healthy Volunteers who have completed 2 doses of COVID-19 AZD1222 vaccine Cohort 6 - Healthy Volunteers who have completed 2 doses of either Pfizer or Moderna mRNA COVID 19 vaccine
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers with low dose vaccination | Experimental | Biological: ChAdOx1-HBV5 Healthy Volunteers receiving low dose vaccination |
| Healthy Volunteers with high dose vaccination | Experimental | Biological: ChAdOx1-HBV5 Healthy Volunteers receiving high dose vaccination |
| Chronic Hepatitis B participants with low dose vaccination | Experimental | Biological: ChAdOx1-HBV6 participants with Chronic Hepatitis B infection receiving low dose vaccination |
| Chronic Hepatitis B participants with high dose vaccination | Experimental | Biological: ChAdOx1-HBV5 participants with Chronic Hepatitis B infection receiving high dose vaccination |
| Healthy Volunteers who have had COVID-19 AZD1222 vaccine | Experimental | Biological: ChAdOx1-HBV15 participants who have had 2 doses of COVID-19 AZD1222 vaccine receiving high dose vaccination. |
| Healthy Volunteers who have had Pfizer/Moderna mRNA COVID 19 vaccine | Experimental | Biological: ChAdOx1-HBV11 participants who have had 2 doses of either Pfizer/Moderna mRNA COVID 19 vaccine receiving high dose vaccination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Adult males or females aged ≥18 to ≤65 years at screening
- Body Mass Index ≤30 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 last dose of study vaccine, not breast feeding
- If female: Not pregnant, and one of the following:
Key exclusion criteria (29 listed)
- Presence of any significant acute or chronic, uncontrolled medical/ psychiatric illness
- Hepatitis C virus antibody positive.
- Human immunodeficiency virus antibody positive
- History or evidence of autoimmune disease or known immunodeficiency of any cause
- Prolonged therapy with immunomodulators (e.g. corticosteroids) or biologics (e.g. monoclonal antibodies, interferon) within 3 months of screening
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-vectored hepatitis B virus vaccine | Biological | Chronic Hepatitis B participants with high dose vaccination, Chronic Hepatitis B participants with low dose vaccination, Healthy Volunteers who have had COVID-19 AZD1222 vaccine, Healthy Volunteers who have had Pfizer/Moderna mRNA COVID 19 vaccine, Healthy Volunteers with high dose vaccination, Healthy Volunteers with low dose vaccination |
Primary outcome
Incidence of Safety and Reactogenicity Events: Adverse Events
Time frame: Recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months)
Adverse events and/or adverse events leading to study discontinuation. Percentages are based on the number of participants in the Safety Analysis Set.
Incidence of Safety and Reactogenicity Events: Serious Adverse Events
Time frame: From day 0 to up to 6 months
Serious adverse events related to the study vaccine. Percentages are based on the number of participants in the Safety Analysis Set.
Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions
Time frame: From day 0 to day 3
Local reactions were collected by the investigator pre and post vaccination on Day 0. In addition, local reactions were captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised.
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Time frame: From day 0 to day 3
Systemic reactions were collected by the investigator pre and post vaccination on Day 0 and captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised.
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
Time frame: Baseline, Day 14, 28, 56, 84
Intracellular cytokine staining analysis to measure IFNγ, produced by HBV antigen or hexon-specific CD8+ T cells in PBMC across study timepoints
11 secondary outcomes
Reduction in HBsAg Titre Post-vaccination in CHB Participants
Time frame: Baseline, Day 28, 56, 84 and 168
Loss of Both HBeAg and HBsAg
Time frame: Baseline and Day 168
Proportion of CHB Participants With HBeAg and HBsAg Seroconversion
Time frame: Baseline, Day 28, 56, 84 and 168
Reduction of Hepatitis B DNA Levels in CHB Participants
Time frame: Baseline, Day 28, 56, 84 and 168
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
Time frame: Baseline, 14, 28, 56, and 84
Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Time frame: Baseline, Day 14, 28, 56, 84 and 168
Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Time frame: Baseline, Day 14, 28, 56, 84 and 168
Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Time frame: Baseline, Day 14, 28, 56, 84 and 168
Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Time frame: Baseline, Day 14, 28, 56, 84 and 168
Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
Time frame: Baseline, Day 14, 28, 84
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
Time frame: Baseline, Day 14, 28, 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37791379Cargill T, Cicconi P, Brown A, Holland L, Karanth B, Rutkowski K, Ashwin E, Mehta R, Chinnakannan S, Sebastian S, Bussey L, Sorensen H, Klenerman P, Evans T, Barnes E. HBV001: Phase I study evaluating the safety and immunogenicity of the therapeutic vaccine ChAdOx1-HBV. JHEP Rep. 2023 Aug 18;5(11):100885. doi: 10.1016/j.jhepr.2023.100885. eCollection 2023 Nov.
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Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
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.
Eleanor Barnes, Prof principal investigator
University of Oxford
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ChAdOx1-HBV in people with Hepatitis B and Healthy, run by Barinthus Biotherapeutics at 4 sites in United Kingdom.
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 24 inclusion and 29 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Safety and Reactogenicity Events: Adverse Events (time frame: Recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04297917, which also lists 1 linked publication.
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 12 Aug 2025.