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

• Status: Unknown status
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mahidol University
• Treatments: Vaccines

Criteria

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