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Immunogenicity of Hepatitis B Vaccination Among Drug Users

Primary Purpose

Hepatitis B Vaccination

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 Vaccination focused on measuring Hepatitis B vaccination, Immunogenicity, Randomized controlled trial, Drug abuse

Eligibility Criteria

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

Inclusion Criteria:

  • Aged between 18 and 70 years at the enrolment
  • current illicit drug users before drug rehabilitation
  • negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
  • having spent acute physiological detoxification phase

Exclusion Criteria:

  • any intolerance or allergy to any component of the vaccine
  • ongoing opportunistic infection
  • liver disease
  • hemopathy
  • cancer
  • unexplained fever in the last week before the recruiting

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    60 µg dose hepatitis B vaccine

    20 µg dose hepatitis B vaccine

    Control

    Arm Description

    Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6

    Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6

    Receive no vaccination during the study period

    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
    Occurrence of Adverse Events After Vaccination
    Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B
    Serious Adverse Events (SAE) Occurred During Month 12

    Full Information

    First Posted
    November 7, 2016
    Last Updated
    December 3, 2021
    Sponsor
    Shanxi Medical University
    Collaborators
    Centers for Disease Control and Prevention, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02959775
    Brief Title
    Immunogenicity of Hepatitis B Vaccination Among Drug Users
    Official Title
    Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (Actual)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    October 2015 (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
    Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection. This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users
    Detailed Description
    Comparison of 2 vaccination strategy against Hepatitis B in Drug Users Intervention: Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6; Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6; Arm 3 : Receive no vaccination during the study period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B Vaccination
    Keywords
    Hepatitis B vaccination, Immunogenicity, Randomized controlled trial, Drug abuse

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    480 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    60 µg dose hepatitis B vaccine
    Arm Type
    Experimental
    Arm Description
    Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6
    Arm Title
    20 µg dose hepatitis B vaccine
    Arm Type
    Experimental
    Arm Description
    Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Receive no vaccination during the study period
    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
    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
    Time Frame
    Within 28 days after the vaccination, at Month 0, 1, and 6
    Title
    Serious Adverse Events (SAE) Occurred During Month 12
    Time Frame
    Month 0-12
    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
    Anti-HBs Concentration at Month 6 Before the Third Injection
    Description
    Anti-HBs concentration at month 6 before the third injection by CMIA
    Time Frame
    Month 6 before the third injection
    Title
    Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection
    Description
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
    Time Frame
    Month 6 before the third injection
    Title
    Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection
    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 6 before the third injection

    10. Eligibility

    Sex
    Male
    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 current illicit drug users before drug rehabilitation negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment having spent acute physiological detoxification phase Exclusion Criteria: any intolerance or allergy to any component of the vaccine ongoing opportunistic infection liver disease hemopathy cancer unexplained fever in the last week before the recruiting
    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
    28301282
    Citation
    Feng Y, Shi J, Gao L, Yao T, Feng D, Luo D, Li Z, Zhang Y, Wang F, Cui F, Li L, Liang X, Wang S. Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-7. doi: 10.1080/21645515.2017.1283082. Epub 2017 Mar 16.
    Results Reference
    result

    Learn more about this trial

    Immunogenicity of Hepatitis B Vaccination Among Drug Users

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