Healthy, Hepatitis B
Conditions
Brief summary
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication. This will be an open-label, non randomised dose escalation study comparing the safety, tolerability and immunogenicity of 2 different doses of ChAdOx1 HBV vaccine. T cell responses in healthy participants who have received a prior two-dose series of AZD1222 will be compared with those who have received either the Pfizer COVID 19 vaccine or the Moderna mRNA COVID 19 vaccine.
Detailed description
This is a first in man human study of a therapeutic vaccine for chronic hepatitis B infection(ChAdOx1-1HBV). The vaccine was given to participants in a dose escalation strategy (two doses). Five healthy participants was administered the low dose first (cohort 1). Dose escalation was only initiated in the next 5 healthy participants (cohort 2) following Safety Monitoring Committee (SMC) review. Six CHB participants was administered the low dose (cohort 3) before the dose escalation was initiated in the remaining 5 CHB participants (cohort 4). Twenty-six healthy participants (15 who have received two doses of AZD1222 \[cohort 5\] and 11 who have received at least two prior doses of Pfizer/Moderna mRNA COVID 19 vaccine \[cohort 6\]) were dosed in parallel with the high dose used in cohorts 2 and 4. Each participant received 1 dose of the vaccine (intramuscular injection). Participants (Volunteers & patients) in cohorts 1 to 4 attended up to 9 study visits and cohorts 5 & 6 attended up to 4 visits in total. The last visit was 24 weeks after vaccination for cohorts 1 to 4 and 12 weeks for cohorts 5 & 6.
Interventions
BIOLOGICALChAdOx1-HBV
chimpanzee adenovirus-vectored hepatitis B virus vaccine
Sponsors
Barinthus Biotherapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The participants were recruited in 6 cohorts as follows - Cohort 1 - Healthy Volunteers - Low dose Vaccine - 5 participants Cohort 2 - Healthy Volunteers - High dose Vaccine - 5 participants Cohort 3 - Participants with Chronic Hepatitis B infection - Low dose - 6 participants Cohort 4 - Participants with Chronic Hepatitis B infection - High dose - 5 participants Cohort 5 - Healthy Volunteers who have completed 2 doses of COVID-19 AZD1222 vaccine Cohort 6 - Healthy Volunteers who have completed 2 doses of either Pfizer or Moderna mRNA COVID 19 vaccine
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult males or females aged ≥18 to ≤65 years at screening 2. Body Mass Index ≤30 kg/m2 3. Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate 4. If female, willing not to become pregnant up to 8 weeks after last dose of study vaccine, not breast feeding 5. If female: Not pregnant, and one of the following: * Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are post menopausal, as defined by no menses in ≥1 year) * Sexual abstinence, only if the participant refrains from heterosexual intercourse during the entire study period and it is the usual lifestyle of the participant * Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to study vaccine and 8 weeks after study vaccine. Highly effective methods of contraception include one or more of the following: Male partner who is sterile (medically effective vasectomy) prior to the female participant's entry into the study and is the sole sexual partner for the female participant, Hormonal (oral, intravaginal, transdermal, implantable or injectable), An intrauterine hormone releasing system, An intrauterine device and Bilateral tubal occlusion Healthy participants (cohorts 1 and 2): 6. Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator Participants with well controlled CHB (cohorts 3 and 4): 7. Documented evidence of chronic HBV infection (e.g. HBsAg positive ≥6 months with detectable HBsAg levels at screening) 8. Receipt of only either entecavir or tenofovir for at least 12 months before screening 9. Virally suppressed (HBV DNA \<40 IU/mL for ≥6 months) 10. HBsAg \<4000IU/mL Participants with well controlled CHB (cohorts 3 and 4): 7\. Documented evidence of chronic HBV infection (e.g. HBsAg positive ≥6 months with detectable HBsAg levels at screening) 8. Receipt of only either entecavir or tenofovir for at least 12 months before screening 9. Virally suppressed (HBV DNA \<40 IU/mL for ≥6 months) 10. HBsAg \<10000 IU/mL Healthy participants (cohort 5): 11\. Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator 12. Adult males or females aged ≥40 to ≤60 years at screening 13. Completed second dose of COVID-19 AZD1222 vaccine 10 to 18 weeks before enrolment Healthy participants (cohort 6): 14\. Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator 15\. Adult males or females aged ≥40 to ≤60 years at screening 16\. Received the latest dose of Completed of either Pfizer (Comirnaty®) or Moderna (Spikevax) mRNA COVID 19 vaccine 6 to 30 weeks before enrolment
Exclusion criteria
1. Presence of any significant acute or chronic, uncontrolled medical/ psychiatric illness 2. Hepatitis C virus antibody positive. 3. Human immunodeficiency virus antibody positive 4. History or evidence of autoimmune disease or known immunodeficiency of any cause 5. Prolonged therapy with immunomodulators (e.g. corticosteroids) or biologics (e.g. monoclonal antibodies, interferon) within 3 months of screening 6. Receipt of immunoglobulin or other blood products within 3 months prior to screening 7. Receipt of any investigational drug or vaccine within 3 months prior to screening 8. Cohorts 1-4: Receipt of any adenoviral vaccine within 3 months prior to administration of ChAdOx1-HBV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0 Cohorts 5 and 6: Receipt of any adenoviral vaccine (other than AZD1222 per inclusion criterion 13) within 3 months prior to administration of ChAdOx1-HBV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0 9. Receipt of any live vaccines within 30 days prior to screening 10. Receipt of any inactivated vaccines within 14 days prior to screening 11. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine 12. Any history of anaphylaxis in reaction to vaccination 13. 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 14. Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant safety and compliance 15. Significant cardiac disease or unstable uncontrolled cardiac disease 16. Any laboratory test at screening which is abnormal and which is deemed by the Investigator to be clinically significant 17. Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study Additionally, for healthy participants (cohorts 1, 2, 5 and 6) 18. HBsAg positive Additionally, for participants with well controlled CHB (cohorts 3 and 4) 19. Co infection with hepatitis delta 20. Documented cirrhosis or advanced fibrosis indicated by a liver biopsy within 6 months prior to screening. In the absence of an appropriate liver biopsy, either 1 of the following: * Screening Fibroscan with a result \>9 kPa within ≤6 months of screening or * Screening FibroTest \>0.48 and aspartate aminotransferase (AST) to platelet ratio index of \>1 In the event of discordant results between non-invasive methods, the Fibroscan result will take precedence. 21. Alanine transaminase (ALT) \>3 × upper limit of normal, international normalised ratio (INR) \>1.5 unless the participant was stable on an anticoagulant regimen affecting INR, albumin \<35 g/L, total bilirubin \>2 mg/dL, platelet count \<100,000/mL 22. A history of liver decompensation (e.g. ascites, encephalopathy or variceal haemorrhage) 23. Prior or current hepatocellular carcinoma 24. Chronic liver disease of a non HBV aetiology 25. Any herbal supplements and or other medicines with potential liver toxicity within the previous 3 months prior to enrolment into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Safety and Reactogenicity Events: Adverse Events | Recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months) | Adverse events and/or adverse events leading to study discontinuation. Percentages are based on the number of participants in the Safety Analysis Set. |
| Incidence of Safety and Reactogenicity Events: Serious Adverse Events | From day 0 to up to 6 months | Serious adverse events related to the study vaccine. Percentages are based on the number of participants in the Safety Analysis Set. |
| Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | From day 0 to day 3 | Local reactions were collected by the investigator pre and post vaccination on Day 0. In addition, local reactions were captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised. |
| Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | From day 0 to day 3 | Systemic reactions were collected by the investigator pre and post vaccination on Day 0 and captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised. |
| Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | Baseline, Day 14, 28, 56, 84 | Intracellular cytokine staining analysis to measure IFNγ, produced by HBV antigen or hexon-specific CD8+ T cells in PBMC across study timepoints |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline, Day 14, 28, 56, 84 and 168 | This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising. |
| Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline, Day 14, 28, 56, 84 and 168 | This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising. |
| Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline, Day 14, 28, 56, 84 and 168 | This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising. |
| Reduction in HBsAg Titre Post-vaccination in CHB Participants | Baseline, Day 28, 56, 84 and 168 | For the CHB participants only. HBsAg levels were measured at each scheduled follow-up timepoint (Day 28, Day 56, Day 84 and Day 168). A summary of the change is obtained by summarising the difference in the log-transformed results \[log(HbsAg at baseline + 1) - log(HbsAg at follow-up + 1)\] and back-transforming to absolute values (IU/mL). The mean change is then the Geometric Mean (GM) ratio, where a GM ratio \> 1 is equivalent to a reduction in HbsAg. |
| Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | Baseline, Day 14, 28, 84 | Intracellular cytokine staining analysis to measure IFNγ, produced by hexon-specific CD4+ T cells in PBMC across study timepoints |
| Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | Baseline, Day 14, 28, 84 | Intracellular cytokine staining analysis to measure IFNγ, produced by hexon-specific CD8+ T cells in PBMC across study timepoints |
| Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline, Day 14, 28, 56, 84 and 168 | This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising. |
| Loss of Both HBeAg and HBsAg | Baseline and Day 168 | For the CHB participants only, loss of HBeAg and HBsAg at the End of Study assessment (Day 168) include all CHB participants in the denominator. Numerators include participants with a) detectable HBeAg and HBsAg at the Day 0 pre-dose assessment and b) undetectable HBeAg and HBsAg at the End of Study assessment. |
| Proportion of CHB Participants With HBeAg and HBsAg Seroconversion | Baseline, Day 28, 56, 84 and 168 | The seroconversion of HBeAg and HBsAg is defined as loss of response to the antigen (defined as a value below the limit of detection (i.e. Not detected) and development of antibody to either HBeAg or surface antigen (HBsAg) (defined as a measurable value above the limit of detection (i.e. Detected). The number and percentage of CHB participants meeting the criteria for seroconversion will be summarised. |
| Reduction of Hepatitis B DNA Levels in CHB Participants | Baseline, Day 28, 56, 84 and 168 | Change in hepatitis B DNA levels is defined by subtracting the DNA levels at each follow-up visit (Day 28, Day 56, Day 84 and Day 168) from the DNA levels pre-vaccination (Day 0). A positive change is equivalent to a reduction in DNA levels. Any results recorded as Not Detected were replaced with zero prior to summarising while any recorded as Detected or 1 (the limit of detection) were replaced with 0.5, prior to summarising. The denominator is the number of participants in the analysis set. |
| Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | Baseline, 14, 28, 56, and 84 | CD4+ and CD8+ cells were analyzed at selected baseline and follow up study visits (Day 0, Day 14, Day 28, Day 56, and/or Day 84) using intracellular cytokine staining (ICS) data from a flow cytometer. Outcome 'A Multiparameter Index Made of CD4+Magnitude, CD4+ Avidity and CD8+ Magnitude' was not calculated. |
Countries
United Kingdom
Participant flow
Pre-assignment details
Fifty-seven (57) participants were screened. Forty-seven (47) subjects were enrolled and vaccinated. The study consisted of 36 healthy participants and 11 participants with CHB and virally suppressed with oral antiviral medication.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers With Low Dose Vaccination 5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine | 5 |
| Healthy Volunteers With High Dose Vaccination 5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine | 5 |
| Chronic Hepatitis B Participants With Low Dose Vaccination 6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine | 6 |
| Chronic Hepatitis B Participants With High Dose Vaccination 5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine | 5 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine 15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine | 15 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine 11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine | 11 |
| Total | 47 |
Baseline characteristics
| Characteristic | Healthy Volunteers With Low Dose Vaccination | Healthy Volunteers With High Dose Vaccination | Chronic Hepatitis B Participants With Low Dose Vaccination | Chronic Hepatitis B Participants With High Dose Vaccination | Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine | Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.6 Years STANDARD_DEVIATION 7.92 | 38.0 Years STANDARD_DEVIATION 5.15 | 39.0 Years STANDARD_DEVIATION 7.51 | 40.8 Years STANDARD_DEVIATION 5.63 | 50.1 Years STANDARD_DEVIATION 6.62 | 50.3 Years STANDARD_DEVIATION 6.92 | 45.2 Years STANDARD_DEVIATION 8.48 |
| BMI at Screening | 23.60 kg/m^2 STANDARD_DEVIATION 2.983 | 25.62 kg/m^2 STANDARD_DEVIATION 1.377 | 22.65 kg/m^2 STANDARD_DEVIATION 2.669 | 23.74 kg/m^2 STANDARD_DEVIATION 3.135 | 25.77 kg/m^2 STANDARD_DEVIATION 2.866 | 25.66 kg/m^2 STANDARD_DEVIATION 2.862 | 24.88 kg/m^2 STANDARD_DEVIATION 2.877 |
| Height at Screening | 173.70 cm STANDARD_DEVIATION 1.107 | 172.92 cm STANDARD_DEVIATION 5.814 | 175.00 cm STANDARD_DEVIATION 11.967 | 162.20 cm STANDARD_DEVIATION 15.515 | 172.34 cm STANDARD_DEVIATION 11.864 | 170.94 cm STANDARD_DEVIATION 8.344 | 171.48 cm STANDARD_DEVIATION 10.467 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 3 Participants | 0 Participants | 12 Participants | 10 Participants | 34 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 7 Participants | 6 Participants | 21 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 4 Participants | 2 Participants | 8 Participants | 5 Participants | 26 Participants |
| Weight at Screening | 71.18 kg STANDARD_DEVIATION 9.03 | 76.80 kg STANDARD_DEVIATION 7.661 | 69.50 kg STANDARD_DEVIATION 10.766 | 63.26 kg STANDARD_DEVIATION 16.646 | 76.65 kg STANDARD_DEVIATION 12.988 | 74.91 kg STANDARD_DEVIATION 8.975 | 73.34 kg STANDARD_DEVIATION 11.691 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 15 | 0 / 11 |
| other Total, other adverse events | 1 / 5 | 4 / 5 | 2 / 6 | 4 / 5 | 8 / 15 | 8 / 11 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 15 | 0 / 11 |
Outcome results
Primary
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
Intracellular cytokine staining analysis to measure IFNγ, produced by HBV antigen or hexon-specific CD8+ T cells in PBMC across study timepoints
Time frame: Baseline, Day 14, 28, 56, 84
Primary
Incidence of Safety and Reactogenicity Events: Adverse Events
Adverse events and/or adverse events leading to study discontinuation. Percentages are based on the number of participants in the Safety Analysis Set.
Time frame: Recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months)
Population: Safety analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with any Adverse Event | 1 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with Adverse Event leading to Study Discontinuation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with any Adverse Event | 4 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with Adverse Event leading to Study Discontinuation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with any Adverse Event | 2 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with Adverse Event leading to Study Discontinuation | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with any Adverse Event | 4 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with Adverse Event leading to Study Discontinuation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with any Adverse Event | 8 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with Adverse Event leading to Study Discontinuation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with any Adverse Event | 8 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Adverse Events | Number of Participants with Adverse Event leading to Study Discontinuation | 0 Participants |
Primary
Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions
Local reactions were collected by the investigator pre and post vaccination on Day 0. In addition, local reactions were captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised.
Time frame: From day 0 to day 3
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Redness - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Pain - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Swelling - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Warmth - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Warmth - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Redness - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Pain - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Swelling - Grade ≥3 Local reactions | 0 participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Redness - Grade ≥3 Local reactions | 0 participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Swelling - Grade ≥3 Local reactions | 0 participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Warmth - Grade ≥3 Local reactions | 0 participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Pain - Grade ≥3 Local reactions | 0 participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Redness - Grade ≥3 Local reactions | 0 participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Swelling - Grade ≥3 Local reactions | 0 participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Warmth - Grade ≥3 Local reactions | 0 participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Pain - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Pain - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Swelling - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Redness - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Warmth - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Warmth - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Swelling - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Redness - Grade ≥3 Local reactions | 0 participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions | Pain - Grade ≥3 Local reactions | 0 participants |
Primary
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Systemic reactions were collected by the investigator pre and post vaccination on Day 0 and captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised.
Time frame: From day 0 to day 3
Population: Safety Analysis Sets
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 0 = None | 5 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 2 = Some interference with daily activities | 1 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 0 = None | 4 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 0 = None | 5 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 0 = None | 4 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 0 = None | 5 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 0 = None | 5 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 1 = No interference with daily activities | 1 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 0 = None | 5 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 0 = None | 5 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 0 = None | 5 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 1 = No interference with daily activities | 1 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 0 = None | 4 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 2 = Some interference with daily activities | 1 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 0 = None | 1 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 1 = No interference with daily activities | 1 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 0 = None | 4 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 2 = Some interference with daily activities | 3 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 1 = No interference with daily activities | 1 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 0 = None | 4 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 2 = Some interference with daily activities | 1 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 1 = No interference with daily activities | 1 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 0 = None | 4 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 0 = None | 4 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 2 = Some interference with daily activities | 1 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 0 = None | 4 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 2 = Some interference with daily activities | 1 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 0 = None | 5 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 0 = None | 4 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 2 = Some interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 1 = No interference with daily activities | 2 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 0 = None | 5 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 0 = None | 5 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 0 = None | 6 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 0 = None | 6 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 0 = None | 3 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 0 = None | 5 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 2 = Some interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 2 = Some interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 2 = Some interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 1 = No interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 2 = Some interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 2 = Some interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 0 = None | 3 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 2 = Some interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 1 = No interference with daily activities | 2 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 1 = No interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 2 = Some interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 0 = None | 4 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 1 = No interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 0 = None | 5 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 2 = Some interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 2 = Some interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 0 = None | 3 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 0 = None | 5 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 2 = Some interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 0 = None | 3 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 2 = Some interference with daily activities | 2 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 2 = Some interference with daily activities | 2 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 0 = None | 4 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 2 = Some interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 0 = None | 4 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 2 = Some interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 0 = None | 5 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 2 = Some interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 0 = None | 4 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 1 = No interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 2 = Some interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 0 = None | 4 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 1 = No interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 2 = Some interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 0 = None | 4 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 1 = No interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 2 = Some interference with daily activities | 1 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 3 = Significant interference with daily activities | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 0 = None | 14 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 0 = None | 15 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 1 = No interference with daily activities | 1 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 0 = None | 15 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 0 = None | 14 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 1 = No interference with daily activities | 1 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 1 = No interference with daily activities | 1 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 0 = None | 14 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 1 = No interference with daily activities | 3 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 0 = None | 15 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 0 = None | 15 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 0 = None | 12 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 0 = None | 15 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 2 = Some interference with daily activities | 1 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 0 = None | 10 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 0 = None | 11 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 1 = No interference with daily activities | 2 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 2 = Some interference with daily activities | 1 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 2 = Some interference with daily activities | 2 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 1 = No interference with daily activities | 1 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 2 = Some interference with daily activities | 2 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 0 = None | 11 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Headache | 0 = None | 8 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 0 = None | 11 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Chills | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 4 = ER visit or hospitalisation | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 1 = No interference with daily activities | 6 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Muscle Ache | 0 = None | 3 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 0 = None | 10 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 2 = Some interference with daily activities | 2 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 1 = No interference with daily activities | 3 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Feverishness | 2 = Some interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Malaise | 0 = None | 9 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Joint Ache | 1 = No interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Nausea | 3 = Significant interference with daily activities | 0 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Fatigue | 0 = None | 6 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions | Temperature | 4 = ER visit or hospitalisation | 0 Participants |
Primary
Incidence of Safety and Reactogenicity Events: Serious Adverse Events
Serious adverse events related to the study vaccine. Percentages are based on the number of participants in the Safety Analysis Set.
Time frame: From day 0 to up to 6 months
Population: Safety Analysis Set - all participants who received at least one vaccination.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | No Events | 5 Participants |
| Healthy Volunteers With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | Participants experiencing Serious Adverse Events | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | No Events | 5 Participants |
| Healthy Volunteers With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | Participants experiencing Serious Adverse Events | 0 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | No Events | 6 Participants |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | Participants experiencing Serious Adverse Events | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | Participants experiencing Serious Adverse Events | 0 Participants |
| Chronic Hepatitis B Participants With High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | No Events | 5 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | Participants experiencing Serious Adverse Events | 0 Participants |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | No Events | 15 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | No Events | 11 Participants |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Incidence of Safety and Reactogenicity Events: Serious Adverse Events | Participants experiencing Serious Adverse Events | 0 Participants |
Secondary
Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
Intracellular cytokine staining analysis to measure IFNγ, produced by hexon-specific CD4+ T cells in PBMC across study timepoints
Time frame: Baseline, Day 14, 28, 84
Population: Immunogenicity Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD4+ IFNy+ Day 0 | 0.018525 Mean CD4+ IFNy+ T cells | Standard Deviation 0.02152 |
| Healthy Volunteers With Low Dose Vaccination | Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD4+ IFNy+ Day 14 | 0.014959 Mean CD4+ IFNy+ T cells | Standard Deviation 0.016946 |
| Healthy Volunteers With Low Dose Vaccination | Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD4+ IFNy+ Day 28 | 0.017065 Mean CD4+ IFNy+ T cells | Standard Deviation 0.013149 |
| Healthy Volunteers With Low Dose Vaccination | Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD4+ IFNy+ Day 84 | 0.020178 Mean CD4+ IFNy+ T cells | Standard Deviation 0.015547 |
| Healthy Volunteers With High Dose Vaccination | Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD4+ IFNy+ Day 84 | 0.033339 Mean CD4+ IFNy+ T cells | Standard Deviation 0.026769 |
| Healthy Volunteers With High Dose Vaccination | Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD4+ IFNy+ Day 0 | 0.016409 Mean CD4+ IFNy+ T cells | Standard Deviation 0.014048 |
| Healthy Volunteers With High Dose Vaccination | Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD4+ IFNy+ Day 28 | 0.054382 Mean CD4+ IFNy+ T cells | Standard Deviation 0.04386 |
| Healthy Volunteers With High Dose Vaccination | Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD4+ IFNy+ Day 14 | 0.047705 Mean CD4+ IFNy+ T cells | Standard Deviation 0.03924 |
Secondary
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
Intracellular cytokine staining analysis to measure IFNγ, produced by hexon-specific CD8+ T cells in PBMC across study timepoints
Time frame: Baseline, Day 14, 28, 84
Population: Immunogenicity Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD8+ IFNy+ Day 0 | 0.055028 Mean CD8+ IFNy+ T cells | Standard Deviation 0.088611 |
| Healthy Volunteers With Low Dose Vaccination | Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD8+ IFNy+ Day 14 | 0.073259 Mean CD8+ IFNy+ T cells | Standard Deviation 0.129767 |
| Healthy Volunteers With Low Dose Vaccination | Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD8+ IFNy+ Day 28 | 0.062521 Mean CD8+ IFNy+ T cells | Standard Deviation 0.076278 |
| Healthy Volunteers With Low Dose Vaccination | Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD8+ IFNy+ Day 84 | 0.057933 Mean CD8+ IFNy+ T cells | Standard Deviation 0.061425 |
| Healthy Volunteers With High Dose Vaccination | Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD8+ IFNy+ Day 84 | 0.183798 Mean CD8+ IFNy+ T cells | Standard Deviation 0.145222 |
| Healthy Volunteers With High Dose Vaccination | Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD8+ IFNy+ Day 0 | 0.085174 Mean CD8+ IFNy+ T cells | Standard Deviation 0.130337 |
| Healthy Volunteers With High Dose Vaccination | Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD8+ IFNy+ Day 28 | 0.261003 Mean CD8+ IFNy+ T cells | Standard Deviation 0.34742 |
| Healthy Volunteers With High Dose Vaccination | Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry | CD8+ IFNy+ Day 14 | 0.295344 Mean CD8+ IFNy+ T cells | Standard Deviation 0.506428 |
Secondary
Loss of Both HBeAg and HBsAg
For the CHB participants only, loss of HBeAg and HBsAg at the End of Study assessment (Day 168) include all CHB participants in the denominator. Numerators include participants with a) detectable HBeAg and HBsAg at the Day 0 pre-dose assessment and b) undetectable HBeAg and HBsAg at the End of Study assessment.
Time frame: Baseline and Day 168
Population: Intent to Treat Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Loss of Both HBeAg and HBsAg | Yes (loss of both HBeAg and HBsAg) | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Loss of Both HBeAg and HBsAg | No | 6 Participants |
| Healthy Volunteers With High Dose Vaccination | Loss of Both HBeAg and HBsAg | Yes (loss of both HBeAg and HBsAg) | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Loss of Both HBeAg and HBsAg | No | 5 Participants |
Secondary
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD4+ and CD8+ cells were analyzed at selected baseline and follow up study visits (Day 0, Day 14, Day 28, Day 56, and/or Day 84) using intracellular cytokine staining (ICS) data from a flow cytometer. Outcome 'A Multiparameter Index Made of CD4+Magnitude, CD4+ Avidity and CD8+ Magnitude' was not calculated.
Time frame: Baseline, 14, 28, 56, and 84
Population: The intention was to correlate the measure to hep B surface antigen response, which was not observed any group. We report available data for CD4+ and CD8+ magnitude from Groups 1, 2, 5, and 6. ICS assays were performed at baseline and at the timepoint of peak total response magnitude where adequate cell numbers were available (Baseline and Day 14, 28, 56, and/or 84 after dosing). No results obtained for Groups 3 and 4 due to insufficient sample volume. Certain time points were not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 28) | 0.013 Percentage of cells | Standard Deviation 0.003 |
| Healthy Volunteers With Low Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 28) | 0.046 Percentage of cells | Standard Deviation 0.022 |
| Healthy Volunteers With Low Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 14) | 0.013 Percentage of cells | Standard Deviation 0.013 |
| Healthy Volunteers With Low Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 14) | 0.022 Percentage of cells | Standard Deviation 0.014 |
| Healthy Volunteers With Low Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 56) | 0.001 Percentage of cells | Standard Deviation 0 |
| Healthy Volunteers With Low Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 56) | 0.293 Percentage of cells | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 56) | 0.023 Percentage of cells | Standard Deviation 0.011 |
| Healthy Volunteers With High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 56) | 0.089 Percentage of cells | Standard Deviation 0.073 |
| Healthy Volunteers With High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 14) | 0.072 Percentage of cells | Standard Deviation 0.044 |
| Healthy Volunteers With High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 28) | 0.005 Percentage of cells | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 28) | 0.000 Percentage of cells | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 14) | 0.013 Percentage of cells | Standard Deviation 0.013 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 0) | 0.019 Percentage of cells | Standard Deviation 0.021 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 14) | 0.015 Percentage of cells | Standard Deviation 0.016 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 28) | 0.017 Percentage of cells | Standard Deviation 0.013 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 84) | 0.020 Percentage of cells | Standard Deviation 0.015 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 0) | 0.055 Percentage of cells | Standard Deviation 0.085 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 14) | 0.073 Percentage of cells | Standard Deviation 0.125 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 28) | 0.063 Percentage of cells | Standard Deviation 0.074 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 84) | 0.058 Percentage of cells | Standard Deviation 0.059 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 84) | 0.033 Percentage of cells | Standard Deviation 0.025 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 28) | 0.054 Percentage of cells | Standard Deviation 0.042 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 84) | 7.148 Percentage of cells | Standard Deviation 23.172 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 28) | 2.365 Percentage of cells | Standard Deviation 7.406 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 14) | 0.048 Percentage of cells | Standard Deviation 0.037 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 0) | 0.076 Percentage of cells | Standard Deviation 0.109 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD4+ (Day 0) | 0.016 Percentage of cells | Standard Deviation 0.013 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination | CD8+ (Day 14) | 1.319 Percentage of cells | Standard Deviation 3.685 |
Secondary
Proportion of CHB Participants With HBeAg and HBsAg Seroconversion
The seroconversion of HBeAg and HBsAg is defined as loss of response to the antigen (defined as a value below the limit of detection (i.e. Not detected) and development of antibody to either HBeAg or surface antigen (HBsAg) (defined as a measurable value above the limit of detection (i.e. Detected). The number and percentage of CHB participants meeting the criteria for seroconversion will be summarised.
Time frame: Baseline, Day 28, 56, 84 and 168
Population: ITT Analysis Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Proportion of CHB Participants With HBeAg and HBsAg Seroconversion | HBsAg Seroconversion | Seroconversion | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Proportion of CHB Participants With HBeAg and HBsAg Seroconversion | HBsAg Seroconversion | No Seroconversion | 6 Participants |
| Healthy Volunteers With Low Dose Vaccination | Proportion of CHB Participants With HBeAg and HBsAg Seroconversion | HBeAg Seroconversion | Seroconversion | 0 Participants |
| Healthy Volunteers With Low Dose Vaccination | Proportion of CHB Participants With HBeAg and HBsAg Seroconversion | HBeAg Seroconversion | No Seroconversion | 6 Participants |
| Healthy Volunteers With High Dose Vaccination | Proportion of CHB Participants With HBeAg and HBsAg Seroconversion | HBeAg Seroconversion | No Seroconversion | 5 Participants |
| Healthy Volunteers With High Dose Vaccination | Proportion of CHB Participants With HBeAg and HBsAg Seroconversion | HBsAg Seroconversion | Seroconversion | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Proportion of CHB Participants With HBeAg and HBsAg Seroconversion | HBeAg Seroconversion | Seroconversion | 0 Participants |
| Healthy Volunteers With High Dose Vaccination | Proportion of CHB Participants With HBeAg and HBsAg Seroconversion | HBsAg Seroconversion | No Seroconversion | 5 Participants |
Secondary
Reduction in HBsAg Titre Post-vaccination in CHB Participants
For the CHB participants only. HBsAg levels were measured at each scheduled follow-up timepoint (Day 28, Day 56, Day 84 and Day 168). A summary of the change is obtained by summarising the difference in the log-transformed results \[log(HbsAg at baseline + 1) - log(HbsAg at follow-up + 1)\] and back-transforming to absolute values (IU/mL). The mean change is then the Geometric Mean (GM) ratio, where a GM ratio \> 1 is equivalent to a reduction in HbsAg.
Time frame: Baseline, Day 28, 56, 84 and 168
Population: Per Protocol population used for HBsAg changes
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Reduction in HBsAg Titre Post-vaccination in CHB Participants | Day 28 | 1.019 ratio | Standard Deviation 1.1569 |
| Healthy Volunteers With Low Dose Vaccination | Reduction in HBsAg Titre Post-vaccination in CHB Participants | Day 56 | 1.086 ratio | Standard Deviation 1.3271 |
| Healthy Volunteers With Low Dose Vaccination | Reduction in HBsAg Titre Post-vaccination in CHB Participants | Day 84 | 0.984 ratio | Standard Deviation 1.3271 |
| Healthy Volunteers With Low Dose Vaccination | Reduction in HBsAg Titre Post-vaccination in CHB Participants | Day 168 | 1.418 ratio | Standard Deviation 1.5074 |
| Healthy Volunteers With High Dose Vaccination | Reduction in HBsAg Titre Post-vaccination in CHB Participants | Day 168 | 1.055 ratio | Standard Deviation 1.0857 |
| Healthy Volunteers With High Dose Vaccination | Reduction in HBsAg Titre Post-vaccination in CHB Participants | Day 28 | 0.957 ratio | Standard Deviation 1.076 |
| Healthy Volunteers With High Dose Vaccination | Reduction in HBsAg Titre Post-vaccination in CHB Participants | Day 84 | 0.901 ratio | Standard Deviation 1.1471 |
| Healthy Volunteers With High Dose Vaccination | Reduction in HBsAg Titre Post-vaccination in CHB Participants | Day 56 | 0.814 ratio | Standard Deviation 1.4126 |
Secondary
Reduction of Hepatitis B DNA Levels in CHB Participants
Change in hepatitis B DNA levels is defined by subtracting the DNA levels at each follow-up visit (Day 28, Day 56, Day 84 and Day 168) from the DNA levels pre-vaccination (Day 0). A positive change is equivalent to a reduction in DNA levels. Any results recorded as Not Detected were replaced with zero prior to summarising while any recorded as Detected or 1 (the limit of detection) were replaced with 0.5, prior to summarising. The denominator is the number of participants in the analysis set.
Time frame: Baseline, Day 28, 56, 84 and 168
Population: Immunogenicity Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Day 28 | -0.333 log 10 IU/ml | Standard Deviation 0.4082 |
| Healthy Volunteers With Low Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Day 84 | -0.425 log 10 IU/ml | Standard Deviation 0.5037 |
| Healthy Volunteers With Low Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Day 56 | -0.455 log 10 IU/ml | Standard Deviation 0.55 |
| Healthy Volunteers With Low Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Day 168 | -0.333 log 10 IU/ml | Standard Deviation 0.5164 |
| Healthy Volunteers With Low Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Baseline | 0.000 log 10 IU/ml | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Day 168 | 0.032 log 10 IU/ml | Standard Deviation 0.7649 |
| Healthy Volunteers With High Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Baseline | 0.432 log 10 IU/ml | Standard Deviation 0.5942 |
| Healthy Volunteers With High Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Day 28 | 0.156 log 10 IU/ml | Standard Deviation 1.0159 |
| Healthy Volunteers With High Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Day 56 | 0.432 log 10 IU/ml | Standard Deviation 0.5942 |
| Healthy Volunteers With High Dose Vaccination | Reduction of Hepatitis B DNA Levels in CHB Participants | Day 84 | 0.198 log 10 IU/ml | Standard Deviation 0.9379 |
Secondary
Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising.
Time frame: Baseline, Day 14, 28, 56, 84 and 168
Population: Immunogenicity Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 148.067 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 33.509 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 99.833 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 66.5061 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day28 | 225.667 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 161.5661 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 49.667 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 68.3171 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 66.333 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 81.8739 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 30.00 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 67.082 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 76.667 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 135.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 38.333 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day28 | 181.667 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 17.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 26.3629 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 5.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 11.1803 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day28 | 39.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 88.5483 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 6.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 13.4164 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 14.200 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 31.7522 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 18.200 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 27.225 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 33.800 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 52.9925 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day28 | 31.400 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 70.2125 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 81.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 83.7425 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 43.060 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 71.5616 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 113.075 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 205.7545 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 62.341 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 72.5715 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 16.111 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 32.4286 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day28 | 51.507 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 107.5817 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day28 | 96.969 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 109.7602 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 60.302 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 65.6994 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 162.727 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 222.4751 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 40.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 70.0317 |
Secondary
Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising.
Time frame: Baseline, Day 14, 28, 56, 84 and 168
Population: Immunogenicity Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 143.333 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 94.441 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 459.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 190.4637 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 61.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 87.4929 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 209.333 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 144.9119 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 254.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 142.9773 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 585.333 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 207.7338 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 385.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 670.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 260.833 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 680.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 22.500 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 31.8198 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 853.333 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 74.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 111.2654 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 55.800 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 103.8663 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 102.200 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 206.8918 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 6.200 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 13.8636 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 64.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 95.8775 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 7.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 15.6525 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 11.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 25.9384 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 13.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 29.0689 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 44.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 85.9349 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 130.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 262.5871 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 15.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 34.8827 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 15.317 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 39.9482 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 40.513 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 122.9345 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 5.238 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 19.5992 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 134.090 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 203.8124 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 68.485 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 124.9477 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 252.727 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 347.2137 |
Secondary
Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising.
Time frame: Baseline, Day 14, 28, 56, 84 and 168
Population: Immunogenicity Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 613.967 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 195.7494 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 385.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 173.8813 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 229.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 142.8947 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 279.167 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 296.0316 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 341.333 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 147.7958 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 691.167 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 164.1345 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 348.750 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 113.7263 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 873.333 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 546.8292 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 918.750 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 429.5674 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 353.333 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 124.9222 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 723.750 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 121.9759 |
| Healthy Volunteers With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 10.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 17.3205 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 24.800 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 36.7859 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 32.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 51.2133 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 25.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 57.2433 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 38.200 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 70.811 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 25.400 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 26.1878 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 32.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 19.0263 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 12.200 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 17.1523 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 20.200 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 31.2282 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 35.400 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 50.2076 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 5.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 11.1803 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 109.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 220.7788 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 19.660 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 27.2365 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 100.256 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 174.3531 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 94.444 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 100.6059 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 46.349 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 76.7025 |
| Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 77.698 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 88.9171 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 163.787 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 108.505 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 79.394 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 76.1256 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 191.818 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 124.9388 |
| Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination | Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 86.364 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 101.3734 |
Secondary
Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising.
Time frame: Baseline, Day 14, 28, 56, 84 and 168
Population: Immunogenicity Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 91.250 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 182.5 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 322.500 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 506.5872 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 12.500 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 25 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 98.750 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 197.5 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 179.042 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 285.1818 |
| Healthy Volunteers With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 119.583 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 239.1667 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 5.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 12.522 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With Low Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Baseline | 5.600 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 12.522 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 28 | 5.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 11.1803 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 56 | 38.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 84.9706 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 84 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 168 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |
| Chronic Hepatitis B Participants With High Dose Vaccination | Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay | Day 14 | 0.000 Spot forming units (SFU) per 10^6 PBMC | Standard Deviation 0 |