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

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine

Treatments: Other: Standard Treatment; Drug: Commercial Hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03405597

13/2560(EC1)

Details and patient eligibility

About

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.

Enrollment: 97 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 3 patient groups

Healthy control

Experimental group

Description:

Commercial Hepatitis B vaccine

Treatment:

Drug: Commercial Hepatitis B vaccine

Chronic hepatitis B with vaccination

Experimental group

Description:

Commercial Hepatitis B vaccine

Treatment:

Drug: Commercial Hepatitis B vaccine

Other: Standard Treatment

Chronic hepatitis B without vaccination

Active Comparator group

Description:

Standard treatment

Treatment:

Other: Standard Treatment