Hepatitis B
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALChAdOx1-HBV
Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
BIOLOGICALMVA-HBV
Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
BIOLOGICALNivolumab
Human immunoglobulin G4 monoclonal antibody
Sponsors
Barinthus Biotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult males or females aged ≥18 to ≤65 years at screening (according to country/local regulations) 2. BMI ≤32kg/m2 3. Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate 4. If 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 5. 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: * oral * intravaginal * transdermal (iii) Progestogen-only hormonal contraception associated with inhibition of ovulation: * oral * injectable * implantable (iv) An intrauterine device (v) Bilateral tubal occlusion 6. Documented evidence of chronic HBV infection (e.g. HBsAg positive ≥6 months with detectable HBsAg levels at screening) 7. Receipt of only either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or besifovir for at least 12 months before screening 8. Virally suppressed (HBV-DNA viral load \< 40 IU/mL for ≥ 1 year) 9. HBsAg levels \<4000 IU/mL
Exclusion criteria
1. Presence of any significant acute or chronic, uncontrolled medical/psychiatric illness 2. Hepatitis C virus (HCV) antibody positive. 3. HIV antibody positive 4. Co-infection with hepatitis D virus 5. 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): * Screening Fibroscan with a result \> 9 kilopascals (kPa) (or the equivalent) within ≤ 6 months of screening, OR * Screening FibroTest \>0.48 and aspartate aminotransferase (AST) to platelet ratio index (APRI) of \>1. 6. 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. 7. A history of liver decompensation (e.g. ascites, encephalopathy or variceal haemorrhage) 8. Prior hepatocellular carcinoma 9. Chronic liver disease of a non-HBV aetiology 10. History or evidence of autoimmune disease or known immunodeficiency of any cause 11. Presence of active infection 12. Evidence of interstitial lung disease, active pneumonitis, myocarditis, or a history of myocarditis 13. Past history of thyroid disorder or abnormal thyroid function at screening that is still active and uncontrolled 14. 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 15. Receipt of immunoglobulin or other blood products within 3 months prior to enrolment 16. Receipt of any investigational drug or vaccine within 3 months prior to screening 17. 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 18. Receipt of any live vaccines within 30 days prior to screening 19. Receipt of any inactivated vaccines within 14 days prior to screening, 20. History of severe hypersensitivity or anaphylactic reactions likely to be exacerbated by any component of the vaccine or nivolumab 21. 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 22. Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant safety and compliance 23. Significant cardiac disease or unstable uncontrolled cardiac disease 24. Any laboratory test which is abnormal, and which is deemed by the Investigator to be clinically significant 25. 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 26. Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | From baseline till Month 9 | 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. |
| The Incidence of Participants With Adverse Events of Special Interest (AESIs) | From study admission (the signature of informed consent) to the end of the study (Month 9) | 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. |
| The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group | From each study vaccination for the following 27 days | 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. |
| Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | From the first vaccination until Month 9 (end of study) | 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. |
| Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | From the first vaccination until Month 9 (end of study) | 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. |
| Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | From baseline till Month 9 | 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. |
| Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | From baseline till Month 9 | 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. |
| The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | From each study vaccination for the following 27 days | 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). |
| The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | From each study vaccination with nivolumab for the following 27 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Reduction in HBsAg Titre | Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9 | 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. |
| Percentage of Participants With HBsAg and HBeAg Loss | Baseline, Month 9 | 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. |
| Percentage of Participants With HBsAg Seroconversion | Baseline and Month 9 | 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. |
| Percentage of Participants With HBeAg Seroconversion | Baseline and Month 9 | 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. |
| Percentage of Participants With Reduction of Hepatitis B DNA | Baseline, Day 35, Month 3 and Month 9 | Changes from baseline will be calculated for each vaccine and for each treatment group. |
| Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9 | 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. |
Countries
South Korea, Taiwan, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 18 |
| 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 | 18 |
| 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 | 9 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 2 (ChAdOx1-HBV, MVA-HBV) | Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Group 1 (MVA-HBV) | Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 18 Participants | 9 Participants | 9 Participants | 54 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 17 Participants | 10 Participants | 8 Participants | 53 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 6 participants | 10 participants | 0 participants | 4 participants | 20 participants |
| Region of Enrollment Taiwan | 11 participants | 6 participants | 10 participants | 3 participants | 30 participants |
| Region of Enrollment United Kingdom | 1 participants | 2 participants | 0 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 1 Participants | 2 Participants | 13 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 9 Participants | 7 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 18 | 0 / 18 | 0 / 9 |
| other Total, other adverse events | 6 / 10 | 8 / 18 | 11 / 18 | 4 / 9 |
| serious Total, serious adverse events | 1 / 10 | 0 / 18 | 1 / 18 | 0 / 9 |
Outcome results
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.
Time frame: From the first vaccination until Month 9 (end of study)
Population: Safety analysis set - participants who received at least one vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Haematology | Clinically Significant | 0 Participants |
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Haematology | Non Clinically Significant | 10 Participants |
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Biochemistry | Clinically Significant | 0 Participants |
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Biochemistry | Non Clinically Significant | 10 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Haematology | Non Clinically Significant | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Biochemistry | Clinically Significant | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Biochemistry | Non Clinically Significant | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Haematology | Clinically Significant | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Biochemistry | Clinically Significant | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Haematology | Non Clinically Significant | 16 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Biochemistry | Non Clinically Significant | 17 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Haematology | Clinically Significant | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Biochemistry | Non Clinically Significant | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Haematology | Non Clinically Significant | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Haematology | Clinically Significant | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator | Biochemistry | Clinically Significant | 0 Participants |
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.
Time frame: From the first vaccination until Month 9 (end of study)
Population: Safety Analysis Set - participants who received at least one vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Pulse Rate | Clinically Significant | 0 Participants |
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Pulse Rate | Non Clinically Significant | 10 Participants |
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Blood Pressure | Clinically Significant | 1 Participants |
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Blood Pressure | Non Clinically Significant | 9 Participants |
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Temperature | Clinically Significant | 0 Participants |
| Group 1 (MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Temperature | Non Clinically Significant | 10 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Temperature | Non Clinically Significant | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Blood Pressure | Non Clinically Significant | 15 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Pulse Rate | Clinically Significant | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Blood Pressure | Clinically Significant | 3 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Pulse Rate | Non Clinically Significant | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Temperature | Clinically Significant | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Pulse Rate | Non Clinically Significant | 17 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Blood Pressure | Clinically Significant | 3 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Blood Pressure | Non Clinically Significant | 15 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Temperature | Non Clinically Significant | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Temperature | Clinically Significant | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Pulse Rate | Clinically Significant | 1 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Temperature | Clinically Significant | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Temperature | Non Clinically Significant | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Pulse Rate | Non Clinically Significant | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Blood Pressure | Non Clinically Significant | 7 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Pulse Rate | Clinically Significant | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator | Blood Pressure | Clinically Significant | 2 Participants |
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.
Time frame: From baseline till Month 9
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Creatinine | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyperkalemia | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypernatremia | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Bilirubin Increase | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyperkalemia | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Aspartate Aminotransferase | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyponatremia | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Bilirubin Increase | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypoalbuminemia | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypoalbuminemia | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypernatremia | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Blood Urea Nitrogen | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alkaline Phosphatase | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Aspartate Aminotransferase | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypokalemia | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Blood Urea Nitrogen | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alanine Aminotransferase | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypokalemia | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyponatremia | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Creatinine | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alkaline Phosphatase | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alanine Aminotransferase | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alanine Aminotransferase | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Creatinine | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypoalbuminemia | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypokalemia | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyperkalemia | Participants with no change | 17 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypokalemia | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Aspartate Aminotransferase | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyperkalemia | Participants with at least two severity grades change | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypoalbuminemia | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alkaline Phosphatase | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypernatremia | Participants with no change | 17 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alkaline Phosphatase | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alanine Aminotransferase | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Bilirubin Increase | Participants with at least two severity grades change | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyponatremia | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypernatremia | Participants with at least two severity grades change | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Bilirubin Increase | Participants with no change | 17 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Blood Urea Nitrogen | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyponatremia | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Blood Urea Nitrogen | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Aspartate Aminotransferase | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Creatinine | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypoalbuminemia | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alanine Aminotransferase | Participants with at least two severity grades change | 2 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alanine Aminotransferase | Participants with no change | 16 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Aspartate Aminotransferase | Participants with at least two severity grades change | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Aspartate Aminotransferase | Participants with no change | 17 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alkaline Phosphatase | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alkaline Phosphatase | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Bilirubin Increase | Participants with at least two severity grades change | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Bilirubin Increase | Participants with no change | 17 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Blood Urea Nitrogen | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Blood Urea Nitrogen | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Creatinine | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Creatinine | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypokalemia | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypokalemia | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyperkalemia | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyperkalemia | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyponatremia | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyponatremia | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypernatremia | Participants with at least two severity grades change | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypernatremia | Participants with no change | 17 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypoalbuminemia | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Creatinine | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypoalbuminemia | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyponatremia | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Blood Urea Nitrogen | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Blood Urea Nitrogen | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypoalbuminemia | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyponatremia | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Bilirubin Increase | Participants with no change | 8 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Bilirubin Increase | Participants with at least two severity grades change | 1 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alanine Aminotransferase | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypernatremia | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alkaline Phosphatase | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alkaline Phosphatase | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Alanine Aminotransferase | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypernatremia | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Aspartate Aminotransferase | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyperkalemia | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypokalemia | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hypokalemia | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Aspartate Aminotransferase | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Hyperkalemia | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters | Creatinine | Participants with no change | 9 Participants |
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.
Time frame: From baseline till Month 9
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Prothrombin time | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Lymphocytes Decrease | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Lymphocytes Decrease | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Eosinophils | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Platelets decrease | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Eosinophils | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Platelets decrease | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC decrease | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC decrease | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Haemoglobin | Participants with no change | 9 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Haemoglobin | Participants with at least two severity grades change | 1 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC increase | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Prothrombin time | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Neutrophils Decrease | Participants with no change | 9 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Neutrophils Decrease | Participants with at least two severity grades change | 1 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC increase | Participants with no change | 10 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Prothrombin time | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC decrease | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC decrease | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC increase | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC increase | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Eosinophils | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Eosinophils | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Lymphocytes Decrease | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Lymphocytes Decrease | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Neutrophils Decrease | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Neutrophils Decrease | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Haemoglobin | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Haemoglobin | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Platelets decrease | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Platelets decrease | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Prothrombin time | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC increase | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Lymphocytes Decrease | Participants with no change | 17 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Neutrophils Decrease | Participants with at least two severity grades change | 2 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC increase | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC decrease | Participants with at least two severity grades change | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Neutrophils Decrease | Participants with no change | 16 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Platelets decrease | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Haemoglobin | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC decrease | Participants with no change | 17 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Prothrombin time | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Haemoglobin | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Eosinophils | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Eosinophils | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Prothrombin time | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Lymphocytes Decrease | Participants with at least two severity grades change | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Platelets decrease | Participants with no change | 18 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Lymphocytes Decrease | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Eosinophils | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Lymphocytes Decrease | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC increase | Participants with at least two severity grades change | 1 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Platelets decrease | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Haemoglobin | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Neutrophils Decrease | Participants with at least two severity grades change | 1 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Prothrombin time | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Prothrombin time | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Platelets decrease | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Neutrophils Decrease | Participants with no change | 8 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC decrease | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Eosinophils | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC increase | Participants with no change | 8 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | Haemoglobin | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters | WBC decrease | Participants with at least two severity grades change | 0 Participants |
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.
Time frame: From baseline till Month 9
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (diastolic) | Participants with no change | 8 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Fever | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (Systolic) | Participants with no change | 9 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Bradycardia | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (diastolic) | Participants with at least two severity grades change | 2 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Tachycardia | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Tachycardia | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Bradycardia | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Fever | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypotension | Participants with at least two severity grades change | 0 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypotension | Participants with no change | 10 Participants |
| Group 1 (MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (Systolic) | Participants with at least two severity grades change | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Bradycardia | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (Systolic) | Participants with at least two severity grades change | 2 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Tachycardia | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (diastolic) | Participants with at least two severity grades change | 3 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (diastolic) | Participants with no change | 15 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (Systolic) | Participants with no change | 16 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Bradycardia | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypotension | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypotension | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Tachycardia | Participants with at least two severity grades change | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Fever | Participants with no change | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Fever | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (Systolic) | Participants with no change | 17 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Bradycardia | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Bradycardia | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Tachycardia | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Tachycardia | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypotension | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypotension | Participants with no change | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (Systolic) | Participants with at least two severity grades change | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (diastolic) | Participants with at least two severity grades change | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (diastolic) | Participants with no change | 17 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Fever | Participants with at least two severity grades change | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Fever | Participants with no change | 18 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypotension | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypotension | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Bradycardia | Participants with at least two severity grades change | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (diastolic) | Participants with no change | 8 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Tachycardia | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Tachycardia | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Fever | Participants with no change | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Fever | Participants with at least two severity grades change | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (Systolic) | Participants with no change | 8 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (Systolic) | Participants with at least two severity grades change | 1 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Bradycardia | Participants with no change | 7 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature) | Hypertension (diastolic) | Participants with at least two severity grades change | 1 Participants |
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.
Time frame: From study admission (the signature of informed consent) to the end of the study (Month 9)
Population: Safety analysis set - all participants who received at least one vaccination
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (MVA-HBV) | The Incidence of Participants With Adverse Events of Special Interest (AESIs) | Participants with Adverse Events of Special Interest (AESI) | 0 Participants |
| Group 1 (MVA-HBV) | The Incidence of Participants With Adverse Events of Special Interest (AESIs) | Participants with no AESI | 10 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Adverse Events of Special Interest (AESIs) | Participants with no AESI | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Adverse Events of Special Interest (AESIs) | Participants with Adverse Events of Special Interest (AESI) | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Adverse Events of Special Interest (AESIs) | Participants with Adverse Events of Special Interest (AESI) | 2 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Adverse Events of Special Interest (AESIs) | Participants with no AESI | 16 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Adverse Events of Special Interest (AESIs) | Participants with Adverse Events of Special Interest (AESI) | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Adverse Events of Special Interest (AESIs) | Participants with no AESI | 9 Participants |
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.
Time frame: From each study vaccination with nivolumab for the following 27 days
Population: All participants who received at least one vaccination and nivolumab.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (MVA-HBV) | The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | Participants experiencing events | 0 Participants |
| Group 1 (MVA-HBV) | The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | No events | 10 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | No events | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | Participants experiencing events | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | Participants experiencing events | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | No events | 17 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | Participants experiencing events | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab | No events | 9 Participants |
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).
Time frame: From each study vaccination for the following 27 days
Population: Safety analysis set - all participants who received at least one vaccination.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Incidence of vaccine related adverse events following vaccination | Participants experiencing events | 1 Participants |
| Group 1 (MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Incidence of vaccine related adverse events following vaccination | No events | 9 Participants |
| Group 1 (MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Grade 3 or greater vaccine related adverse events following vaccination | Participants experiencing events | 0 Participants |
| Group 1 (MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Grade 3 or greater vaccine related adverse events following vaccination | No events | 10 Participants |
| Group 1 (MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Serious Adverse Events vaccine related following vaccination | Participants experiencing events | 0 Participants |
| Group 1 (MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Serious Adverse Events vaccine related following vaccination | No events | 10 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Serious Adverse Events vaccine related following vaccination | No events | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Grade 3 or greater vaccine related adverse events following vaccination | No events | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Incidence of vaccine related adverse events following vaccination | Participants experiencing events | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Grade 3 or greater vaccine related adverse events following vaccination | Participants experiencing events | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Incidence of vaccine related adverse events following vaccination | No events | 17 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Serious Adverse Events vaccine related following vaccination | Participants experiencing events | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Incidence of vaccine related adverse events following vaccination | No events | 16 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Grade 3 or greater vaccine related adverse events following vaccination | Participants experiencing events | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Grade 3 or greater vaccine related adverse events following vaccination | No events | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Serious Adverse Events vaccine related following vaccination | No events | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Serious Adverse Events vaccine related following vaccination | Participants experiencing events | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Incidence of vaccine related adverse events following vaccination | Participants experiencing events | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Serious Adverse Events vaccine related following vaccination | Participants experiencing events | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Serious Adverse Events vaccine related following vaccination | No events | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Incidence of vaccine related adverse events following vaccination | No events | 8 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Grade 3 or greater vaccine related adverse events following vaccination | No events | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Incidence of vaccine related adverse events following vaccination | Participants experiencing events | 1 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination | Grade 3 or greater vaccine related adverse events following vaccination | Participants experiencing events | 0 Participants |
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.
Time frame: From each study vaccination for the following 27 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group | Participants experiencing events | 6 Participants |
| Group 1 (MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group | No events | 4 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group | No events | 10 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group | Participants experiencing events | 8 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group | Participants experiencing events | 11 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group | No events | 7 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group | Participants experiencing events | 4 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group | No events | 5 Participants |
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.
Time frame: Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9
Population: Immunogenicity Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pol 3+4) | 0.0152 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Core) | -0.0089 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Core) | -0.0165 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Core) | -0.0099 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Core) | 0.0128 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Core) | 0.0068 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pol 1+2) | 0.0068 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pol 1+2) | 0.0063 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pol 1+2) | 0.0046 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pol 1+2) | 0.0068 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pol 1+2) | 0.0235 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pol 1+2) | 0.0066 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Core) | 0.0034 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pol 3+4) | -0.0076 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pol 3+4) | 0.0052 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pol 3+4) | 0.0109 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pol 3+4) | 0.0066 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pol 3+4) | 0.0058 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pre-S1/S2+S) | 0.0071 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pre-S1/S2+S) | 0.0022 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pre-S1/S2+S) | -0.0162 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pre-S1/S2+S) | -0.0166 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pre-S1/S2+S) | 0.0107 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pre-S1/S2+S) | 0.0052 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Core) | 0.0027 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Core) | 0.0054 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Core) | -0.0194 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Core) | -0.0364 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Core) | 0.0108 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Core) | 0.0000 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pol 1+2) | 0.0000 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pol 1+2) | 0.0000 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pol 1+2) | 0.0000 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pol 1+2) | 0.0146 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pol 1+2) | 0.0058 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pol 1+2) | 0.0000 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pol 3+4) | 0.0189 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pol 3+4) | -0.0075 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pol 3+4) | -0.0021 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pol 3+4) | 0.0375 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pol 3+4) | 0.0318 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pol 3+4) | 0.0478 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pre-S1/S2+S) | 0.0054 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pre-S1/S2+S) | 0.0000 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pre-S1/S2+S) | -0.0093 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pre-S1/S2+S) | -0.0304 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pre-S1/S2+S) | 0.0481 percentage of cells |
| Group 1 (MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pre-S1/S2+S) | 0.0012 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pol 3+4) | -0.0035 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Core) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pol 3+4) | 0.0022 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pre-S1/S2+S) | 0.0195 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pre-S1/S2+S) | 0.0042 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Core) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pol 1+2) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pol 1+2) | 0.0054 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pol 1+2) | -0.0040 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Core) | 0.0003 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pol 3+4) | 0.0096 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pol 1+2) | 0.0009 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pol 1+2) | 0.0018 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Core) | 0.0147 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pol 3+4) | 0.0069 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pre-S1/S2+S) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pol 1+2) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Core) | 0.0145 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pol 1+2) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pol 1+2) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pre-S1/S2+S) | 0.0065 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Core) | 0.0092 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Core) | -0.0033 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pol 1+2) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pol 1+2) | -0.0011 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pre-S1/S2+S) | -0.0372 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pol 3+4) | 0.0093 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pol 3+4) | 0.0051 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Core) | -0.0163 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pre-S1/S2+S) | 0.0058 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pol 3+4) | 0.0180 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pre-S1/S2+S) | 0.0385 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pre-S1/S2+S) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pre-S1/S2+S) | 0.0031 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pol 1+2) | 0.0000 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Core) | 0.0058 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pol 3+4) | 0.0068 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pre-S1/S2+S) | 0.0005 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pol 3+4) | 0.0131 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Core) | -0.0009 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pol 3+4) | 0.0007 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pre-S1/S2+S) | -0.0119 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pol 3+4) | 0.0028 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Core) | 0.0050 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pol 3+4) | -0.0055 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pre-S1/S2+S) | -0.0011 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pol 1+2) | 0.0025 percentage of cells |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Core) | -0.0131 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pol 3+4) | -0.0034 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pol 3+4) | -0.0023 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pol 3+4) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pol 3+4) | 0.0110 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pol 3+4) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pol 3+4) | 0.0120 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pre-S1/S2+S) | -0.0130 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pol 3+4) | 0.0154 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pol 3+4) | 0.0138 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pre-S1/S2+S) | -0.0173 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pre-S1/S2+S) | -0.0210 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pre-S1/S2+S) | -0.0363 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pre-S1/S2+S) | -0.0319 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pol 3+4) | 0.0412 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pre-S1/S2+S) | -0.0202 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pre-S1/S2+S) | -0.0249 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pre-S1/S2+S) | 0.0215 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Core) | -0.0010 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Core) | -0.0203 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pre-S1/S2+S) | -0.0034 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Core) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Core) | -0.0204 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Core) | -0.0219 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Core) | 0.0038 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pre-S1/S2+S) | -0.0130 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pol 1+2) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pol 1+2) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pol 1+2) | 0.0010 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pol 1+2) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pre-S1/S2+S) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pol 1+2) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pol 1+2) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Core) | 0.0050 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Core) | -0.0003 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pol 3+4) | 0.0322 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Core) | -0.0003 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Core) | 0.0051 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Core) | -0.0213 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Core) | -0.0107 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pol 3+4) | 0.0004 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pol 1+2) | 0.0020 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pol 1+2) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pre-S1/S2+S) | -0.0292 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pol 1+2) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pol 1+2) | 0.0002 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pol 3+4) | 0.0477 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pol 1+2) | 0.0000 percentage of cells |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pol 1+2) | 0.0000 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Core) | -0.0231 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pre-S1/S2+S) | -0.0270 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pol 1+2) | -0.0155 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Core) | -0.0016 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pol 3+4) | -0.0634 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pre-S1/S2+S) | -0.0215 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pol 3+4) | -0.0232 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Core) | -0.0051 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pol 1+2) | -0.0196 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pre-S1/S2+S) | 0.0158 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pol 1+2) | -0.0162 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Core) | -0.0024 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pol 3+4) | -0.0443 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pre-S1/S2+S) | -0.0260 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pol 3+4) | -0.0430 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Core) | -0.0142 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pre-S1/S2+S) | -0.0304 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pol 3+4) | -0.0585 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 35 (Pol 3+4) | -0.0191 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Core) | 0.0197 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pre-S1/S2+S) | -0.0117 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Pol 3+4) | -0.0267 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pol 3+4) | 0.0144 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 9 (Core) | -0.0260 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 3 (Pol 1+2) | -0.0149 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Core) | -0.0001 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Month 6 (Pol 3+4) | -0.0232 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pol 1+2) | -0.0018 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pre-S1/S2+S) | -0.0120 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Core) | -0.0061 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pol 3+4) | -0.0218 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pol 1+2) | -0.0276 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pre-S1/S2+S) | 0.0006 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pre-S1/S2+S) | -0.0246 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 7 (Pol 1+2) | -0.0162 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pol 1+2) | -0.0401 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Core) | 0.0008 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 7 (Pre-S1/S2+S) | -0.0574 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Pol 3+4) | -0.0161 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pol 1+2) | 0.0000 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 3 (Pre-S1/S2+S) | -0.0390 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Core) | 0.0000 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pol 3+4) | -0.0324 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 6 (Pol 1+2) | -0.0085 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 35 (Pre-S1/S2+S) | -0.0446 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Day 28 (Core) | -0.0011 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD4+ Change from Baseline to Day 28 (Pol 1+2) | -0.0155 percentage of cells |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen | CD8+ Change from Baseline to Month 9 (Pol 1+2) | -0.0152 percentage of cells |
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.
Time frame: Baseline and Month 9
Population: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (MVA-HBV) | Percentage of Participants With HBeAg Seroconversion | Seroconversion | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With HBeAg Seroconversion | No Seroconversion | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With HBeAg Seroconversion | No Seroconversion | 3 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With HBeAg Seroconversion | Seroconversion | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With HBeAg Seroconversion | No Seroconversion | 3 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With HBeAg Seroconversion | Seroconversion | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With HBeAg Seroconversion | Seroconversion | 1 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With HBeAg Seroconversion | No Seroconversion | 2 Participants |
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.
Time frame: Baseline, Month 9
Population: Intent to Treat Analysis Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (MVA-HBV) | Percentage of Participants With HBsAg and HBeAg Loss | HBsAg Seroconversion at Month 9 | Seroconversion | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With HBsAg and HBeAg Loss | HBsAg Seroconversion at Month 9 | No Seroconversion | 9 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With HBsAg and HBeAg Loss | HBeAg Seroconversion1 at Month 9 | Seroconversion | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With HBsAg and HBeAg Loss | HBeAg Seroconversion1 at Month 9 | No Seroconversion | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With HBsAg and HBeAg Loss | HBsAg Seroconversion at Month 9 | No Seroconversion | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With HBsAg and HBeAg Loss | HBeAg Seroconversion1 at Month 9 | Seroconversion | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With HBsAg and HBeAg Loss | HBeAg Seroconversion1 at Month 9 | No Seroconversion | 3 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With HBsAg and HBeAg Loss | HBsAg Seroconversion at Month 9 | Seroconversion | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg and HBeAg Loss | HBeAg Seroconversion1 at Month 9 | Seroconversion | 2 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg and HBeAg Loss | HBsAg Seroconversion at Month 9 | No Seroconversion | 15 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg and HBeAg Loss | HBeAg Seroconversion1 at Month 9 | No Seroconversion | 3 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg and HBeAg Loss | HBsAg Seroconversion at Month 9 | Seroconversion | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg and HBeAg Loss | HBeAg Seroconversion1 at Month 9 | No Seroconversion | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg and HBeAg Loss | HBsAg Seroconversion at Month 9 | No Seroconversion | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg and HBeAg Loss | HBsAg Seroconversion at Month 9 | Seroconversion | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg and HBeAg Loss | HBeAg Seroconversion1 at Month 9 | Seroconversion | 1 Participants |
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.
Time frame: Baseline and Month 9
Population: ITT Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (MVA-HBV) | Percentage of Participants With HBsAg Seroconversion | No seroconversion (i.e., HBsAg > LLoQ) at Month 9 | 9 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With HBsAg Seroconversion | Seroconversion (i.e., HBsAg < LLoQ) at Month 9 | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With HBsAg Seroconversion | Seroconversion (i.e., HBsAg < LLoQ) at Month 9 | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With HBsAg Seroconversion | No seroconversion (i.e., HBsAg > LLoQ) at Month 9 | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg Seroconversion | No seroconversion (i.e., HBsAg > LLoQ) at Month 9 | 15 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg Seroconversion | Seroconversion (i.e., HBsAg < LLoQ) at Month 9 | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg Seroconversion | No seroconversion (i.e., HBsAg > LLoQ) at Month 9 | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With HBsAg Seroconversion | Seroconversion (i.e., HBsAg < LLoQ) at Month 9 | 0 Participants |
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.
Time frame: Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9
Population: Per Protocol population used for HBsAg changes
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | > 0.5 log10 | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | No log change or <0.5 log10 | 9 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | No log change or <0.5 log10 | 9 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | No log change or <0.5 log10 | 8 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | > 1.0 log10 | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | > 0.5 log10 | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | > 0.5 log10 | 1 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | No log change or <0.5 log10 | 8 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | No log change or <0.5 log10 | 10 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | > 0.5 log10 | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | > 1.0 log10 | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | > 0.5 log10 | 1 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | > 0.5 log10 | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | > 1.0 log10 | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | No log change or <0.5 log10 | 9 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | > 1.0 log10 | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | > 1.0 log10 | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | > 1.0 log10 | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | No log change or <0.5 log10 | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | > 0.5 log10 | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | > 1.0 log10 | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | > 0.5 log10 | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | > 1.0 log10 | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | No log change or <0.5 log10 | 17 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | > 0.5 log10 | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | > 1.0 log10 | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | No log change or <0.5 log10 | 18 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | > 0.5 log10 | 3 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | > 1.0 log10 | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | No log change or <0.5 log10 | 14 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | > 0.5 log10 | 3 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | > 1.0 log10 | 2 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | No log change or <0.5 log10 | 13 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | > 0.5 log10 | 3 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | > 1.0 log10 | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | No log change or <0.5 log10 | 14 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | > 1.0 log10 | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | > 0.5 log10 | 7 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | > 1.0 log10 | 4 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | > 0.5 log10 | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | No log change or <0.5 log10 | 8 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | No log change or <0.5 log10 | 7 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | > 1.0 log10 | 4 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | > 0.5 log10 | 4 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | No log change or <0.5 log10 | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | > 1.0 log10 | 4 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | > 0.5 log10 | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | No log change or <0.5 log10 | 10 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | > 1.0 log10 | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | > 0.5 log10 | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | No log change or <0.5 log10 | 18 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | > 1.0 log10 | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | > 0.5 log10 | 5 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | No log change or <0.5 log10 | 18 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | > 0.5 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | > 0.5 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | > 1.0 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | > 0.5 log10 | 1 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | > 0.5 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | > 0.5 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | > 1.0 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | > 1.0 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | > 1.0 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | No log change or <0.5 log10 | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | No log change or <0.5 log10 | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 3 | No log change or <0.5 log10 | 8 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 7 | No log change or <0.5 log10 | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 28 | No log change or <0.5 log10 | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | No log change or <0.5 log10 | 9 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 6 | > 0.5 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Day 35 | > 1.0 log10 | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction in HBsAg Titre | Loss from Baseline to Month 9 | > 1.0 log10 | 0 Participants |
Secondary
Percentage of Participants With Reduction of Hepatitis B DNA
Changes from baseline will be calculated for each vaccine and for each treatment group.
Time frame: Baseline, Day 35, Month 3 and Month 9
Population: ITT Analysis Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | No HBV DNA detected | 6 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | No HBV DNA detected | 8 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | < 20 IU/mL HBV DNA detected | 1 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | No HBV DNA detected | 10 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | < 20 IU/mL HBV DNA detected | 3 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | No HBV DNA detected | 7 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | < 20 IU/mL HBV DNA detected | 3 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 1 (MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | < 20 IU/mL HBV DNA detected | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | No HBV DNA detected | 16 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | < 20 IU/mL HBV DNA detected | 2 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | No HBV DNA detected | 10 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | < 20 IU/mL HBV DNA detected | 7 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | ≥ 20 IU/mL HBV DNA detected | 1 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | No HBV DNA detected | 14 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | < 20 IU/mL HBV DNA detected | 4 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | No HBV DNA detected | 16 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | < 20 IU/mL HBV DNA detected | 2 Participants |
| Group 2 (ChAdOx1-HBV, MVA-HBV) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | < 20 IU/mL HBV DNA detected | 1 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | No HBV DNA detected | 13 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | No HBV DNA detected | 14 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | < 20 IU/mL HBV DNA detected | 5 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | < 20 IU/mL HBV DNA detected | 4 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | No HBV DNA detected | 16 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | No HBV DNA detected | 10 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | < 20 IU/mL HBV DNA detected | 6 Participants |
| Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | ≥ 20 IU/mL HBV DNA detected | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | < 20 IU/mL HBV DNA detected | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | No HBV DNA detected | 7 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | No HBV DNA detected | 7 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Baseline | < 20 IU/mL HBV DNA detected | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | ≥ 20 IU/mL HBV DNA detected | 0 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | < 20 IU/mL HBV DNA detected | 1 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 3 | < 20 IU/mL HBV DNA detected | 2 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Day 35 | No HBV DNA detected | 8 Participants |
| Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab) | Percentage of Participants With Reduction of Hepatitis B DNA | Month 9 | No HBV DNA detected | 7 Participants |