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Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

Primary Purpose

Hepatitis B Vaccine

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
60 µg dose hepatitis B vaccine
20 µg dose hepatitis B vaccine
Sponsored by
Shanxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B Vaccine focused on measuring Hepatitis B, Vaccine, Immunogenicity, methadone maintenance treatment, Randomized Controlled Trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged between 18 and 70 years at the enrolment
  • Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
  • Willing to adhere to the study protocol

Exclusion Criteria:

  • Being pregnant
  • Intolerance or allergy to any component of the vaccine
  • Any vaccination during the month preceding enrollment
  • Ongoing opportunistic infection
  • Liver disease
  • Hematological disorder
  • Cancer
  • Unexplained fever the week before enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    60 µg dose hepatitis B vaccine

    20 µg dose hepatitis B vaccine

    Arm Description

    60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

    20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

    Outcomes

    Primary Outcome Measures

    Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml.

    Secondary Outcome Measures

    Anti-HBs Concentration at Month 7
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Anti-HBs Concentration at Month 12
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
    Occurrence of Adverse Events After Vaccination
    Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
    Occurrence of Adverse Events After Vaccination
    Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
    Anti-HBs Concentration at Month 18
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
    Anti-HBs Concentration at Month 30
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
    Anti-HBs Concentration at Month 42
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml

    Full Information

    First Posted
    December 10, 2016
    Last Updated
    November 26, 2021
    Sponsor
    Shanxi Medical University
    Collaborators
    Centers for Disease Control and Prevention, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02991599
    Brief Title
    Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
    Official Title
    Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    May 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanxi Medical University
    Collaborators
    Centers for Disease Control and Prevention, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in methadone maintenance treatment patients.
    Detailed Description
    Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone Maintenance Treatment Intervention: Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6; Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B Vaccine
    Keywords
    Hepatitis B, Vaccine, Immunogenicity, methadone maintenance treatment, Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    196 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    60 µg dose hepatitis B vaccine
    Arm Type
    Experimental
    Arm Description
    60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
    Arm Title
    20 µg dose hepatitis B vaccine
    Arm Type
    Experimental
    Arm Description
    20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
    Intervention Type
    Biological
    Intervention Name(s)
    60 µg dose hepatitis B vaccine
    Intervention Description
    three-dose, 60 µg per dose
    Intervention Type
    Biological
    Intervention Name(s)
    20 µg dose hepatitis B vaccine
    Intervention Description
    three-dose, 20 µg per dose
    Primary Outcome Measure Information:
    Title
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml.
    Time Frame
    Month 7
    Secondary Outcome Measure Information:
    Title
    Anti-HBs Concentration at Month 7
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Time Frame
    Month 7
    Title
    Anti-HBs Concentration at Month 12
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Time Frame
    Month 12
    Title
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
    Time Frame
    Month 12
    Title
    Occurrence of Adverse Events After Vaccination
    Description
    Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
    Time Frame
    Within 7 days after the vaccination, at Month 0, 1, and 6
    Title
    Occurrence of Adverse Events After Vaccination
    Description
    Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
    Time Frame
    Within 28 days after the vaccination, at Month 0, 1, and 6
    Title
    Anti-HBs Concentration at Month 18
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Time Frame
    Month 18
    Title
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
    Time Frame
    Month 18
    Title
    Anti-HBs Concentration at Month 30
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Time Frame
    Month 30
    Title
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
    Time Frame
    Month 30
    Title
    Anti-HBs Concentration at Month 42
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
    Time Frame
    Month 42
    Title
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml
    Time Frame
    Month 42
    Other Pre-specified Outcome Measures:
    Title
    Number and Rate of Participants With Anti-HBs High-level Response at Month 7
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
    Time Frame
    Month 7
    Title
    Number and Rate of Participants With Anti-HBs High-level Response at Month 12
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
    Time Frame
    Month 12
    Title
    Number and Rate of Participants With Anti-HBs High-level Response at Month 18
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
    Time Frame
    Month 18
    Title
    Number and Rate of Participants With Anti-HBs High-level Response at Month 30
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
    Time Frame
    Month 30
    Title
    Number and Rate of Participants With Anti-HBs High-level Response at Month 42
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
    Time Frame
    Month 42

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged between 18 and 70 years at the enrolment Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment Willing to adhere to the study protocol Exclusion Criteria: Being pregnant Intolerance or allergy to any component of the vaccine Any vaccination during the month preceding enrollment Ongoing opportunistic infection Liver disease Hematological disorder Cancer Unexplained fever the week before enrollment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suping Wang
    Organizational Affiliation
    Shanxi Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28343774
    Citation
    Shi J, Feng Y, Gao L, Feng D, Yao T, Shi S, Zhang Y, Liang X, Wang S. Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial. Vaccine. 2017 Apr 25;35(18):2443-2448. doi: 10.1016/j.vaccine.2017.03.034. Epub 2017 Mar 23.
    Results Reference
    result

    Learn more about this trial

    Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

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