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

Phase 3

• Conditions: Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine
• Interventions: Drug: Commercial Hepatitis B vaccine; Other: Standard Treatment

• Registration Number: NCT03405597
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-30
• Status Verified: 2018-01
• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-12
• Last Update Submitted: 2018-01-12
• Study First Posted: 2018-01-23
• Last Update Posted: 2018-01-23
• Primary Completion: 2018-02-28
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 97

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy control	Commercial Hepatitis B vaccine	Commercial Hepatitis B vaccine
Chronic hepatitis B with vaccination	Standard Treatment	Commercial Hepatitis B vaccine
Chronic hepatitis B with vaccination	Commercial Hepatitis B vaccine	Commercial Hepatitis B vaccine
Chronic hepatitis B without vaccination	Standard Treatment	Standard treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand