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Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults (HIV)

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, HIV, Immunogenicity

Eligibility Criteria

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

Inclusion Criteria:

  • HIV-infected
  • Aged between 18 and 70 years
  • 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 before or during the month preceding enrollment
  • Any Intolerance or allergy to any component of the vaccine
  • Ongoing opportunistic infection
  • Hematological disorder
  • Cancer
  • Unexplained fever the week before enrollment
  • Immunosuppressive or immunomodulating treatment in the last six months
  • Liver disease

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 Percentage 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 ).
    Number and Percentage 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.
    Anti-HBs Concentration at Month 12
    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
    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
    Serious Adverse Events (SAE) Occurred During 42 Month
    Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B

    Full Information

    First Posted
    October 17, 2017
    Last Updated
    December 27, 2021
    Sponsor
    Suping Wang
    Collaborators
    Centers for Disease Control and Prevention, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03316807
    Brief Title
    Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
    Acronym
    HIV
    Official Title
    Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in HIV-infected Adults in China
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (Actual)
    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
    Uptake, adherence, and completion of vaccination among HIV-infected adults 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 HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge. This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.
    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, HIV, Immunogenicity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    182 (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 Percentage 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
    Number and Percentage 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
    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
    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 vaccination
    Title
    Serious Adverse Events (SAE) Occurred During 42 Month
    Description
    Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B
    Time Frame
    Month 0-42
    Other Pre-specified Outcome Measures:
    Title
    Number and Percentage 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 Percentage 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 Percentage of Participants With Anti-HBs Antibodies 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
    Anti-HBs Concentration at Month 6 Before the Third Injection
    Description
    Anti-HBs concentration at month 6 before the third injection as measured by CMIA（Chemiluminescent Microparticle Immunoassay）.
    Time Frame
    Month 6 before the third injection
    Title
    Number and Percentage 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
    Title
    Number and Percentage 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

    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: HIV-infected Aged between 18 and 70 years 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 before or during the month preceding enrollment Any Intolerance or allergy to any component of the vaccine Ongoing opportunistic infection Hematological disorder Cancer Unexplained fever the week before enrollment Immunosuppressive or immunomodulating treatment in the last six months Liver disease
    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
    34052065
    Citation
    Feng Y, Yao T, Chang Y, Gao L, Shao Z, Dong S, Wu Y, Shi X, Shi J, Feng D, Cheng Y, Pan M, Li C, Wang J, Lan G, Lu H, Wang P, Xiang S, Nong L, Wang F, Liang X, Wang S. Immunogenicity and persistence of high-dose recombinant hepatitis B vaccine in adults infected with human immunodeficiency virus in China: A randomized, double-blind, parallel controlled trial. Vaccine. 2021 Jun 16;39(27):3582-3589. doi: 10.1016/j.vaccine.2021.05.044. Epub 2021 May 26.
    Results Reference
    derived

    Learn more about this trial

    Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults

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