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

January 12, 2018 updated by: Mahidol University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

97

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital
        • Contact:
          • Chairat Shayakul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBsAb level at 4 weeks after complete vaccine injection
Time Frame: an average of 7 months
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
Time Frame: an average of 1 year
HBsAb level more than 10 mIU/ml at 6 months
an average of 1 year
Adverse event from HBV vaccine
Time Frame: an average of 1 year
Any adverse event from HBV vaccine by CTCAE v4.0
an average of 1 year
Factors associated with HBV vaccine response
Time Frame: an average of 1 year
Factors associated with HBV vaccine response at 12 months
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Tawesak Tanwandee, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2017

Primary Completion (Anticipated)

February 28, 2018

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/2560(EC1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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