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Immunogenicity of Hepatitis B Vaccination in Hemodialysis 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
Suping Wang
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, Randomized Controlled Trial, Hemodialysis, Immunogenicity

Eligibility Criteria

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

Inclusion Criteria:

  • Having end-stage renal disease (ESRD) on maintenance hemodialysis
  • Aged between 18 and 70 years at enrollment
  • 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
  • Acute cytolysis in the last three months before enrollment
  • Any vaccination during the month preceding enrollment
  • Intolerance or allergy to any component of the vaccine
  • Ongoing opportunistic infection
  • Hepatitis C virus infection
  • Hematological disorder
  • Cancer
  • Unexplained fever the week before enrollment
  • Immunosuppressive or immunomodulating treatment in the last six months
  • Renal transplantation or upcoming renal transplantation
  • Liver disease
  • Other immunocompromised condition not related to ESRD
  • An expected survival of < 6 months

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

    Anti-HBs Seroconversion Rate at Month 7

    Secondary Outcome Measures

    Anti-HBs Seroconversion Rate at Month 42
    Anti-HBs Seroconversion Rate at Month 36
    Anti-HBs Seroconversion Rate at Month 30
    Anti-HBs Seroconversion Rate at Month 24
    Anti-HBs Concentration at Month 7
    Anti-HBs concentration at month 7 as measured by CMIA
    Anti-HBs Concentration at Month 12
    Anti-HBs concentration at month 12 as measured by CMIA
    Anti-HBs Seroconversion Rate at Month 12
    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 Seroconversion Rate at Month 18

    Full Information

    First Posted
    November 8, 2016
    Last Updated
    November 26, 2021
    Sponsor
    Suping Wang
    Collaborators
    Centers for Disease Control and Prevention, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02963714
    Brief Title
    Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
    Official Title
    Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Suping Wang
    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
    Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge. 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 hemodialysis patients.
    Detailed Description
    Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

    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, Randomized Controlled Trial, Hemodialysis, Immunogenicity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    352 (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
    Anti-HBs Seroconversion Rate at Month 7
    Time Frame
    Month 7
    Secondary Outcome Measure Information:
    Title
    Anti-HBs Seroconversion Rate at Month 42
    Time Frame
    Month 42
    Title
    Anti-HBs Seroconversion Rate at Month 36
    Time Frame
    Month 36
    Title
    Anti-HBs Seroconversion Rate at Month 30
    Time Frame
    Month 30
    Title
    Anti-HBs Seroconversion Rate at Month 24
    Time Frame
    Month 24
    Title
    Anti-HBs Concentration at Month 7
    Description
    Anti-HBs concentration at month 7 as measured by CMIA
    Time Frame
    Month 7
    Title
    Anti-HBs Concentration at Month 12
    Description
    Anti-HBs concentration at month 12 as measured by CMIA
    Time Frame
    Month 12
    Title
    Anti-HBs Seroconversion Rate at Month 12
    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
    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
    Title
    Anti-HBs Seroconversion Rate at Month 18
    Time Frame
    Month 18
    Other Pre-specified Outcome Measures:
    Title
    High-level Response Rate at Month 7
    Time Frame
    Month 7
    Title
    High-level Response Rate at Month 12
    Time Frame
    Month 12
    Title
    High-level Response Rate at Month 18
    Time Frame
    Month 18
    Title
    High-level Response Rate at Month 30
    Time Frame
    Month 30
    Title
    High-level Response Rate at Month 36
    Time Frame
    Month 36
    Title
    High-level Response Rate at Month 42
    Time Frame
    Month 42
    Title
    High-level Response Rate at Month 24
    Time Frame
    Month 24

    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: Having end-stage renal disease (ESRD) on maintenance hemodialysis Aged between 18 and 70 years at enrollment 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 Acute cytolysis in the last three months before enrollment Any vaccination during the month preceding enrollment Intolerance or allergy to any component of the vaccine Ongoing opportunistic infection Hepatitis C virus infection Hematological disorder Cancer Unexplained fever the week before enrollment Immunosuppressive or immunomodulating treatment in the last six months Renal transplantation or upcoming renal transplantation Liver disease Other immunocompromised condition not related to ESRD An expected survival of < 6 months
    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
    28803502
    Citation
    Feng Y, Shi X, Shi J, Gao L, Liu G, Cheng Y, Pan M, Li C, Wang J, Guo X, Zhang Y, Liang X, Wang S. Immunogenicity, antibody persistence, and safety of the 60 mug hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial. Expert Rev Vaccines. 2017 Oct;16(10):1045-1052. doi: 10.1080/14760584.2017.1367667. Epub 2017 Aug 21.
    Results Reference
    result

    Learn more about this trial

    Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

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