Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine
Conditions
Brief summary
Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion. There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.
Interventions
Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6
OTHERStandard Treatment
HBsAg, HBsAb test Ultrasound upper abdomen every 6 months
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Chronic Hepatitis B infection group * 18-80 year-old * Compensated liver disease * Chronic HBV infection with or without NUCs treatment * History of HBsAg positive \> 6 months * HBsAg negative with qualitative Elecsys (Roche) twice at least 6 months apart * HBsAb negative * HBV DNA \< 20 IU/mL Healthy group * Healthy person without history of HBV vaccination (HBsAg, anti-HBc and HBsAb negative)
Exclusion criteria
* History of previous HBV vaccination * Anti-HCV and/or anti-HIV positive * Decompensated cirrhosis * History of previous malignancies * History or currently receive immunotherapy, cytotoxic or immunosuppressive agents * Patient with immunodeficiency disease * Creatinine \> 1.5 mg/dL * Pregnancy or lactating woman * Unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBsAb level at 4 weeks after complete vaccine injection | an average of 7 months | HBsAb level more than 10 mIU/ml at 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBsAb level at 6 months after complete vaccine injection | an average of 1 year | HBsAb level more than 10 mIU/ml at 6 months |
| Adverse event from HBV vaccine | an average of 1 year | Any adverse event from HBV vaccine by CTCAE v4.0 |
| Factors associated with HBV vaccine response | an average of 1 year | Factors associated with HBV vaccine response at 12 months |
Countries
Thailand
Contacts
Primary ContactSuppawat Jiraphairot
Backup ContactTawesak Tanwandee
Outcome results
None listed