| Eligibility |
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
|
