HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg

Study Overview
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Brief Summary
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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.

Official Title
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HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg

Conditions
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Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine

Intervention / Treatment
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* Drug: Commercial Hepatitis B vaccine
* Other: Standard Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy control<br>Commercial Hepatitis B vaccine | Drug: Commercial Hepatitis B vaccine<br>* Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6<br>* Other names: Engerix B;|
| Experimental: Chronic hepatitis B with vaccination<br>Commercial Hepatitis B vaccine | Drug: Commercial Hepatitis B vaccine<br>* Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6<br>* Other names: Engerix B;Other: Standard Treatment<br>* HBsAg, HBsAb test Ultrasound upper abdomen every 6 months<br>|
| Active Comparator: Chronic hepatitis B without vaccination<br>Standard treatment | Other: Standard Treatment<br>* HBsAg, HBsAb test Ultrasound upper abdomen every 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBsAb level at 4 weeks after complete vaccine injection | HBsAb level more than 10 mIU/ml at 7 months | an average of 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBsAb level at 6 months after complete vaccine injection | HBsAb level more than 10 mIU/ml at 6 months | an average of 1 year | 
| Adverse event from HBV vaccine | Any adverse event from HBV vaccine by CTCAE v4.0 | an average of 1 year | 
| Factors associated with HBV vaccine response | Factors associated with HBV vaccine response at 12 months | an average of 1 year |