Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000190-25 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a multi-centre study conducted in 52 participants, who will each be administered 2 vaccine injections (IM) on Day 0 and Day 28 as follows:
Group 1: MVA-HBV + MVA-HBV (now closed) Group 2: ChAdOx1-HBV + MVA-HBV Group 3: ChAdOx1-HBV + MVA-HBV + nivolumab (IV infusion) Group 4: ChAdOx1-HBV + nivolumab + MVA-HBV + nivolumab (now closed)
Participants are randomised to treatment as the groups are initiated with a 1:1:1:1 allocation. Version 6.0 of the study protocol has closed Groups 1 and 4 to further randomisation; recruitment will now be in a 1:1 ratio between Groups 2 and 3 only. A sentinel participant is dosed in Group 1, with further participants in Group 1 only being dosed at least 48h later. Group 2 is initiated following a Day 7 safety assessment of the first 6 participants in Group 1. Groups 3 and 4 are initiated following a Day 7 safety assessment of the first 6 participants in Group 2.
The primary 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.
The secondary objectives of the study are the determination of the immunogenicity of the ChAdOx1-HBV and MVA-HBV vaccines and the impact of PD-blockade, as well as the effect on HBV markers; these are assessed by measurements of the magnitude and avidity of HBV-specific CD4+ and CD8+ T cells and the magnitude of HBV markers.
Following first vaccination, participants remain in the study for 9 months and attend clinic visits for vaccination and assessments on Days 0, 7, 28, 35 and Months, 3, 6 and 9.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (MVA-HBV) | Experimental | Day 0: MVA-HBV 1 x 10^8 pfu IM injection Day 28: MVA-HBV 1 x 10^8 pfu IM injection |
|
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Experimental | Day 0: ChAdOx1-HBV 1 x 2.5 10^10 vp IM injection Day 28: MVA-HBV 1 x 10^8 pfu IM injection |
|
| Group 3 (ChAdOx1-HBV, MVA-HBV and nivolumab) | Experimental | 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 |
|
| Group 4 (ChAdOx1-HBV and nivolumab, MVA-HBV and nivolumab) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAdOx1-HBV | Biological | Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | The incidence of TEAEs and and ≥Grade 3 study vaccine-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 vaccine administration; they will be further categorised by Seriousness, Severity (i.e. ≥ Grade 3) and Causality. Seriousness of the TEAEs is assessed according to the published FDA criteria (2016). Severity of the TEAEs will be graded according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adults and Volunteers Enrolled in Preventative Vaccine Trials, 2007 (70 FR 22664). | From each study vaccination for the following 27 days |
| The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | The incidence of ≥Grade 3 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 vaccine administration with nivolumab; they are further categorised by Seriousness, Severity (i.e. ≥ Grade 3) according to FDA Guidance 70 FR 22664 and Causality. | From each study vaccination with nivolumab for the following 27 days |
| The Incidence of Participants With Adverse Events of Special Interest (AESIs) | The incidence of AESIs will be based on the number and percentage of participants with events and number of events. 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. | From study admission (the signature of informed consent) to the end of the study (Month 9) |
| The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | The frequency of HBV-specific CD4+ and CD8+ T cells was determined by stimulating Peripheral Blood Mononuclear Cells (PBMC) with peptide pools corresponding to HBV antigens Core, Polymerase and Surface in an Intracellular Cytokine Staining (ICS) flow cytometry assay. In this assay the percentage of CD4+ or CD8+ expressing cytokines IFNγ, IL-2 or TNFα in response to HBV peptides is measured. Frequencies of antigen-specific cytokine-expressing CD4+ or CD8+ T cells are compared across trial timepoints and treatment groups. |
Not provided
Inclusion Criteria:
Adult males or females aged ≥18 to ≤65 years at screening (according to country/local regulations)
BMI ≤32kg/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 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 post menopausal, as defined by no menses in ≥1 year and without an alternative medical cause)
Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to study vaccine and 8 weeks after study vaccine and 5 months after the last dose of nivolumab. Highly effective methods of contraception include one or more of the following:
(i) 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
(ii) Combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
(iii) Progestogen-only hormonal contraception associated with inhibition of ovulation:
(iv) An intrauterine device
(v) Bilateral tubal occlusion
Documented evidence of chronic HBV infection (e.g. HBsAg positive ≥6 months with detectable HBsAg levels at screening)
Receipt of only either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or besifovir for at least 12 months before screening
Virally suppressed (HBV-DNA viral load < 40 IU/mL for ≥ 1 year)
HBsAg levels <4000 IU/mL
Exclusion Criteria:
Presence of any significant acute or chronic, uncontrolled medical/psychiatric illness
Hepatitis C virus (HCV) antibody positive.
HIV antibody positive
Co-infection with hepatitis D virus
Documented cirrhosis or advanced fibrosis indicated by a liver biopsy within 6 months prior to screening (Metavir activity grade A3 and stages F3 and F4; Ishak stages 4-6).
In the absence of a documented liver biopsy, either 1 of the following (not both):
ALT >3 x upper limit of normal (ULN), international normalized ratio (INR) >1.5 unless the participant was stable on an anticoagulant regimen affecting INR, albumin <3.5 g/dL, direct bilirubin >1.5 x ULN, platelet count < 100,000/microlitre.
A history of liver decompensation (e.g. ascites, encephalopathy or variceal haemorrhage)
Prior hepatocellular carcinoma
Chronic liver disease of a non-HBV aetiology
History or evidence of autoimmune disease or known immunodeficiency of any cause
Presence of active infection
Evidence of interstitial lung disease, active pneumonitis, myocarditis, or a history of myocarditis
Past history of thyroid disorder or abnormal thyroid function at screening that is still active and uncontrolled
Prolonged therapy with immunomodulators (e.g. corticosteroids such as prednisone > 10 mg/day) or biologics (e.g. monoclonal antibodies, IFN) within 3 months of screening
Receipt of immunoglobulin or other blood products within 3 months prior to enrolment
Receipt of any investigational drug or vaccine within 3 months prior to screening
Receipt of any adenoviral-based 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
Receipt of any live vaccines within 30 days prior to screening
Receipt of any inactivated vaccines within 14 days prior to screening,
History of severe hypersensitivity or anaphylactic reactions likely to be exacerbated by any component of the vaccine or nivolumab
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 which is abnormal, and which is deemed by the Investigator to be clinically significant
Cytotoxic agents, other anti HBV or traditional herbal medicines which, in the opinion of the Investigator, may have activity against HBV within the previous 6 months prior to randomization
Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | 492421 | South Korea | |||
| Kyungpook National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40932107 | Derived | Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine |
| FG001 | Group 2 (ChAdOx1-HBV, MVA-HBV) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2021 | Jan 31, 2024 |
Not provided
Participants are randomised to the four treatment groups, as the groups are initiated. Allocation to the groups is 1:1:1:1. Version 6.0 of the study protocol has closed Groups 1 and 4 to further randomisation; recruitment will now be in a 1:1 ratio between Groups 2 and 3 only.
Not provided
Not provided
Not provided
Not provided
| MVA-HBV | Biological | Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine |
|
| Nivolumab | Biological | Human immunoglobulin G4 monoclonal antibody |
|
|
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 four study groups.
| From each study vaccination for the following 27 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. | From the first vaccination until Month 9 (end of study) |
| 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. | From the first vaccination until Month 9 (end of study) |
| 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. | From baseline till Month 9 |
| 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. | From baseline till Month 9 |
| 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. | From baseline till Month 9 |
| Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9 |
| Percentage of Participants With Reduction in HBsAg Titre | This will be determined from samples of PBMCs. The percentage of participants with a HBsAg loss >0.5 log10 and >1.0 log10 will be determined for each vaccine and for each treatment group. | Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9 |
| Percentage of Participants With HBsAg and HBeAg Loss | The proportion of participants infected with HBsAg-positive virus at baseline who develop Hepatitis B surface antigen antibody will be determined for each vaccine and for each treatment group. The proportion of participants infected with HBeAg-positive virus at baseline who develop Hepatitis B e-antigen antibody will be determined for each vaccine and for each treatment group. | Baseline, Month 9 |
| Percentage of Participants With HBsAg Seroconversion | The proportion of participants infected with HBsAg-positive virus at baseline who become HBsAg negative will be determined for each vaccine and for each treatment group. The times to seroconversion will be calculated in months. | Baseline and Month 9 |
| Percentage of Participants With HBeAg Seroconversion | This will be determined from samples of PBMCs. The proportion of participants infected with HBeAg-positive virus at baseline who become HBeAg negative will be determined for each vaccine and for each treatment group. The times to seroconversion will be calculated in months. | Baseline and Month 9 |
| Percentage of Participants With Reduction of Hepatitis B DNA | Changes from baseline will be calculated for each vaccine and for each treatment group. | Baseline, Day 35, Month 3 and Month 9 |
| Daegu |
| 41944 |
| South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Yonsei University College of Medicine | Seoul | 03722 | South Korea |
| Asan Medical Centre | Seoul | 05505 | South Korea |
| The Catholic University of Korea Seoul Saint Mary's Hospital | Seoul | 06591 | South Korea |
| Buddhist Tzu Chi Medical Foundation | Dalin | Chia-Yi County | 62247 | Taiwan |
| E-Da Hospital | Kaohsiung City | Yan-chao District | 82445 | Taiwan |
| Chia-Yi Christian Hospital | Chiayi City | 60002 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Nottingham University Hospitals NHS Trust | Nottingham | Notts | NG7 2UH | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
Day 0: ChAdOx1-HBV 1 x 2.5 10^10 vp IM injection Day 28: MVA-HBV 1 x 10^8 pfu IM injection
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
| FG002 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| FG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) analysis set consisted of all participants who were randomised.
Safety analysis set consisted of all participants who received at least 1 vaccination.
Per-protocol (PP) analysis set consisted of all participants in the safety analysis set who received the correct trial vaccine and who had no major protocol deviations.
Immunogenicity analysis set consisted of all participants in the PP set who had available immunogenicity data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine |
| BG001 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine |
| BG002 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| BG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | The incidence of TEAEs and and ≥Grade 3 study vaccine-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 vaccine administration; they will be further categorised by Seriousness, Severity (i.e. ≥ Grade 3) and Causality. Seriousness of the TEAEs is assessed according to the published FDA criteria (2016). Severity of the TEAEs will be graded according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adults and Volunteers Enrolled in Preventative Vaccine Trials, 2007 (70 FR 22664). | Safety analysis set - all participants who received at least one vaccination. | Posted | Count of Participants | Participants | From each study vaccination for the following 27 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | The incidence of ≥Grade 3 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 vaccine administration with nivolumab; they are further categorised by Seriousness, Severity (i.e. ≥ Grade 3) according to FDA Guidance 70 FR 22664 and Causality. | All participants who received at least one vaccination and nivolumab. | Posted | Count of Participants | Participants | From each study vaccination with nivolumab for the following 27 days |
| |||||||||||||||||||||||||||||||||||||
| Primary | The Incidence of Participants With Adverse Events of Special Interest (AESIs) | The incidence of AESIs will be based on the number and percentage of participants with events and number of events. 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. | Safety analysis set - all participants who received at least one vaccination | Posted | Count of Participants | Participants | From study admission (the signature of informed consent) to the end of the study (Month 9) |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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 four study groups. | Posted | Count of Participants | Participants | From each study vaccination for the following 27 days |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety analysis set - participants who received at least one vaccination | Posted | Count of Participants | Participants | From the first vaccination until Month 9 (end of study) |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety Analysis Set - participants who received at least one vaccination | Posted | Count of Participants | Participants | From the first vaccination until Month 9 (end of study) |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Statistical Analysis Plan changed analysis of laboratory results so that shift tables of laboratory results, vital signs, and physical examinations were summarised using the worst post-baseline result overall, rather than by time point as indicated in the protocol. | Posted | Count of Participants | Participants | From baseline till Month 9 |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Statistical analysis Plan has changed the planned analysis so that shift tables of laboratory results were summarised using the worst post-baseline result overall, rather than by time point as indicated in the protocol. | Posted | Count of Participants | Participants | From baseline till Month 9 |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Statistical Analysis Plan changed planned analysis so that shift tables of laboratory results, vital signs, and physical examinations were summarised using the worst post-baseline result overall, rather than by time point as indicated in the protocol. | Posted | Count of Participants | Participants | From baseline till Month 9 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | The frequency of HBV-specific CD4+ and CD8+ T cells was determined by stimulating Peripheral Blood Mononuclear Cells (PBMC) with peptide pools corresponding to HBV antigens Core, Polymerase and Surface in an Intracellular Cytokine Staining (ICS) flow cytometry assay. In this assay the percentage of CD4+ or CD8+ expressing cytokines IFNγ, IL-2 or TNFα in response to HBV peptides is measured. Frequencies of antigen-specific cytokine-expressing CD4+ or CD8+ T cells are compared across trial timepoints and treatment groups. | Immunogenicity Analysis Set | Posted | Median | 95% Confidence Interval | percentage of cells | Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Reduction in HBsAg Titre | This will be determined from samples of PBMCs. The percentage of participants with a HBsAg loss >0.5 log10 and >1.0 log10 will be determined for each vaccine and for each treatment group. | Per Protocol population used for HBsAg changes | Posted | Count of Participants | Participants | Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBsAg and HBeAg Loss | The proportion of participants infected with HBsAg-positive virus at baseline who develop Hepatitis B surface antigen antibody will be determined for each vaccine and for each treatment group. The proportion of participants infected with HBeAg-positive virus at baseline who develop Hepatitis B e-antigen antibody will be determined for each vaccine and for each treatment group. | Intent to Treat Analysis Set | Posted | Count of Participants | Participants | Baseline, Month 9 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBsAg Seroconversion | The proportion of participants infected with HBsAg-positive virus at baseline who become HBsAg negative will be determined for each vaccine and for each treatment group. The times to seroconversion will be calculated in months. | ITT Analysis Set | Posted | Count of Participants | Participants | Baseline and Month 9 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBeAg Seroconversion | This will be determined from samples of PBMCs. The proportion of participants infected with HBeAg-positive virus at baseline who become HBeAg negative will be determined for each vaccine and for each treatment group. The times to seroconversion will be calculated in months. | ITT Analysis Set The overall number of particpants analyized is made up of number of participants who are HBeAg positive at baseline and have non-missing HBeAg results at Month 9. This results in a smaller analysis population than the total participants for each group | Posted | Count of Participants | Participants | Baseline and Month 9 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Reduction of Hepatitis B DNA | Changes from baseline will be calculated for each vaccine and for each treatment group. | ITT Analysis Set | Posted | Count of Participants | Participants | Baseline, Day 35, Month 3 and Month 9 |
|
Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months
Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit.
Serious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine | 0 | 10 | 1 | 10 | 6 | 10 |
| EG001 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine | 0 | 18 | 0 | 18 | 8 | 18 |
| EG002 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody | 0 | 18 | 1 | 18 | 11 | 18 |
| EG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody | 0 | 9 | 0 | 9 | 4 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RHEGMATOGENOUS RETINAL DETACHMENT OD (RIGHT EYE (OCULUS DEXTER) | Eye disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| POLYPOSIS OVER RIGHT MAXILARY SINUSITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Laryngopharyngitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Intestinal metaplasia | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Rapid eye movement sleep behaviour disorder | Psychiatric disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 26.0 | Non-systematic Assessment |
|
There is an agreement restricting the right of the Participating Organisation and/or Principal Investigator to publish trial results, which may not be before the first multi-site publication. Following this, Participating Organisation and/or Principal Investigator may publish results, subject to Sponsor's prior review and comment (within 60 days). Sponsor can request a delay of publication up to six (6) months to enable protection of its proprietary information and/or IPR and know-how.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Barinthus Biotherapeutics | +44 (0) 1865 818 808 | clinicaltrials@barinthusbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2023 | Jan 31, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Taiwan |
|
| United Kingdom |
|
| No events |
|
| Grade 3 or greater vaccine related adverse events following vaccination |
|
| Serious Adverse Events vaccine related following vaccination |
|
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
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
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| OG002 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| OG002 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| OG002 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| OG002 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
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
ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
Nivolumab: Human immunoglobulin G4 monoclonal antibody
| OG003 | 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| OG003 |
| 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 ChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine MVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine Nivolumab: Human immunoglobulin G4 monoclonal antibody |
|
|
| Non Clinically Significant |
|
| Non Clinically Significant |
|
| Non Clinically Significant |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
| Participants with no change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| > 1.0 log10 |
|
| No log change or <0.5 log10 |
|
| Title | Measurements |
|---|---|
| > 0.5 log10 |
|
| > 1.0 log10 |
|
| No log change or <0.5 log10 |
|
| Title | Measurements |
|---|---|
| > 0.5 log10 |
|
| > 1.0 log10 |
|
| No log change or <0.5 log10 |
|
| Title | Measurements |
|---|---|
| > 0.5 log10 |
|
| > 1.0 log10 |
|
| No log change or <0.5 log10 |
|
| Title | Measurements |
|---|---|
| > 0.5 log10 |
|
| > 1.0 log10 |
|
| No log change or <0.5 log10 |
|
| Title | Measurements |
|---|---|
| > 0.5 log10 |
|
| > 1.0 log10 |
|
| No log change or <0.5 log10 |
|
| No Seroconversion |
|
|
| < 20 IU/mL HBV DNA detected |
|
| ≥ 20 IU/mL HBV DNA detected |
|
| Title | Measurements |
|---|---|
| No HBV DNA detected |
|
| < 20 IU/mL HBV DNA detected |
|
| ≥ 20 IU/mL HBV DNA detected |
|
| Title | Measurements |
|---|---|
| No HBV DNA detected |
|
| < 20 IU/mL HBV DNA detected |
|
| ≥ 20 IU/mL HBV DNA detected |
|
| Title | Measurements |
|---|---|
| No HBV DNA detected |
|
| < 20 IU/mL HBV DNA detected |
|
| ≥ 20 IU/mL HBV DNA detected |
|