Patients with occult hepatitis B (OBI) as defined by chronic hepatitis B carrier, with documented loss of HBsAg, negative anti-HBs, positive anti-HBc and negative HBV DNA. Infections and Infestations
Conditions
Interventions
Recruited patients will be randomised into 3 groups in the ratio of 1:1:1. Each patient will receive a 3-dose Sci-B-Vac™ regime or placebo at 0, 1 and 6 months. Group 1 will receive a total of 10µg in
Group 2 will receive a total of 10µg intramuscular HBsAg each time with topical imiquimod ointment pretreatment
Group 3 will receive a total of 10µg intradermal HBsAg each time with topical aqueous cream pretreatment.
Sponsors
University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects recruited have to be aged =18 years with no history of previous hepatitis B vaccination, with documentation of loss of HBsAg without anti-HBs production during follow-up of the chronic hepatitis B infection, with normal liver function tests and negative HBV DNA 2. Subjects have to give written informed consent 3. Subjects must be available to complete the study and comply with study procedures
Exclusion criteria
Exclusion criteria: 1. Subjects with a history or any illness that might interfere with the results of the study or participation in the study may pose additional risk to the subjects 2. Subjects have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination 3. Subjects have a known allergy to components of the study vaccine Sci-B-Vac™ 4. Subjects have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding 5. Subjects have an active neoplastic disease or a history of any hematologic malignancy 6. Subjects have known chronic active hepatitis C (anti-HCV+ve), autoimmune hepatitis or cirrhosis 7. Subjects have known active human immunodeficiency virus infection (anti-HIV+ve) 8. Subjects have received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study 9. Subjects participate in another clinical study during the current study 10. Subjects have axillary temperature =38°C or oral temperature =38.5°C within 3 days of intended study vaccination 11. Subjects have a history of alcohol or drug abuse in the last 5 years 12. Subjects have any condition that the investigator believes may interfere with successful completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with anti-HBs antibody titre =10 IU/L at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Seroconversion and seroprotection rate at 1, 6 and 12 months after the first first dose of vaccination 2. The GMT fold increase at 1, 6 and 12 months 3. Safety and side effects after vaccination | — |
Countries
Hong Kong
Contacts
Public ContactIvan FN Hung
Outcome results
None listed