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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control | Experimental | Commercial Hepatitis B vaccine |
|
| Chronic hepatitis B with vaccination | Experimental | Commercial Hepatitis B vaccine |
|
| Chronic hepatitis B without vaccination | Active Comparator | Standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercial Hepatitis B vaccine | Drug | Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Chronic Hepatitis B infection group
Healthy group
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suppawat Jiraphairot | Contact | +66 877116517 | suppawat_tu@hotmail.com | |
| Tawesak Tanwandee | Contact | +66 24197281 | 102 | tawesak@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tawesak Tanwandee | Department of Medicine, Faculty of medicine Siriraj Hospital, Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital | Recruiting | Bangkoknoi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22087128 | Background | Taheri H, Hasanjani Roushan MR, Soleimani Amiri MJ, Pouralijan M, Bijani A. Efficacy of Hepatitis B vaccine in those who lost Hepatitis B surface antigen during follow-up: Efficacy of HBV vaccine in those who lost HBsAg. Hepat Mon. 2011 Feb;11(2):119-22. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C075654 | Engerix-B |
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|
| Standard Treatment | Other | HBsAg, HBsAb test Ultrasound upper abdomen every 6 months |
|
| 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 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |