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

Sponsor
Mahidol University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03405597
Collaborator
(none)
97
Enrollment
1
Location
3
Arms
15
Anticipated Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Commercial Hepatitis B vaccine
  • Other: Standard Treatment
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg
Actual Study Start Date :
Mar 30, 2017
Anticipated Primary Completion Date :
Feb 28, 2018
Anticipated Study Completion Date :
Jun 30, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. HBsAb level at 6 months after complete vaccine injection [an average of 1 year]

      HBsAb level more than 10 mIU/ml at 6 months

    2. Adverse event from HBV vaccine [an average of 1 year]

      Any adverse event from HBV vaccine by CTCAE v4.0

    3. Factors associated with HBV vaccine response [an average of 1 year]

      Factors associated with HBV vaccine response at 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Siriraj Hospital Bangkoknoi Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT03405597
    Other Study ID Numbers:
    • 13/2560(EC1)
    First Posted:
    Jan 23, 2018
    Last Update Posted:
    Jan 23, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Hepatitis, Chronic

    Study Results

    No Results Posted as of Jan 23, 2018