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出境医 / 临床实验 / Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients

Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients

Study Description
Brief Summary:

At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.

This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients


Condition or disease Intervention/treatment Phase
Hepatitis B Vaccine Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 Phase 4

Detailed Description:
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in HIV-Infected Patients
Estimated Study Start Date : June 5, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: 20 µg at months 0, 1, and 6
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
 Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
three-dose, 20 µg per dose
Experimental: 20 µg at months 0, 1, 2,and 6
20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
 Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 20 µg per dose
Experimental: 60 µg at months 0, 1, 2,and 6
60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
 Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 60 µg per dose
Outcome Measures
Primary Outcome Measures :
  1. Anti-HBs Seroconversion Rate at Month 7 [ Time Frame: Month 7 ]
    Anti-HBs Seroconversion Rate at month 7 as measured by CMIA


Secondary Outcome Measures :
  1. Anti-HBs concentration at month 7 [ Time Frame: Month 7 ]
    Anti-HBs concentration at month 7 as measured by CMIA

  2. Occurrence of Adverse Events After Vaccination [ Time Frame: Within 7 days after the vaccination ]
    Occurrence of adverse reactions within 7 days after vaccination with the hepatitis

  3. Anti-HBs Seroconversion Rate at month 12 [ Time Frame: Month 12 ]
    Anti-HBs Seroconversion Rate at month 12 as measured by CMIA

  4. Anti-HBs concentration at month 12 [ Time Frame: Month 12 ]
    Anti-HBs concentration at month 12 as measured by CMIA

  5. Anti-HBs Seroconversion Rate at month 18 [ Time Frame: Month 18 ]
    Anti-HBs Seroconversion Rate at month 18 as measured by CMIA

  6. Anti-HBs concentration at month 18 [ Time Frame: Month 18 ]
    Anti-HBs concentration at month 18 as measured by CMIA

  7. Anti-HBs Seroconversion Rate at month 30 [ Time Frame: Month 30 ]
    Anti-HBs Seroconversion Rate at month 30 as measured by CMIA

  8. Anti-HBs concentration at month 30 [ Time Frame: Month 30 ]
    Anti-HBs concentration at month 30 as measured by CMIA

  9. Anti-HBs Seroconversion Rate at month 42 [ Time Frame: Month 42 ]
    Anti-HBs Seroconversion Rate at month 42 as measured by CMIA

  10. Anti-HBs concentration at month 42 [ Time Frame: Month 42 ]
    Anti-HBs concentration at month 42 as measured by CMIA


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
  • Sign informed consent, willing to participate in this study

Exclusion Criteria:

  • Being pregnant
  • Intolerance or allergy to any component of the vaccine
  • Any vaccination during the month preceding enrollment
  • CD4 cell count ≤ 200 cells/µL
  • Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
  • The use of immunosuppressive agents in patients with nearly three months
Contacts and Locations

Contacts
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Contact: Suping Wang, PhD #86-351-4135103 spwang88@163.com
Contact: Yongliang Feng, PhD #86-351-4135362 fengyongliang048@163.com

Locations
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China
Shanxi Center for Disease Control and Prevention
Taiyuan, China
Sponsors and Collaborators
Shanxi Medical University
Centers for Disease Control and Prevention, China
Investigators
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Principal Investigator: Suping Wang, PhD Shanxi Medical University
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date May 24, 2019
Estimated Study Start Date  ICMJE June 5, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		Anti-HBs Seroconversion Rate at Month 7 [ Time Frame: Month 7 ]
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Anti-HBs concentration at month 7 [ Time Frame: Month 7 ]
    Anti-HBs concentration at month 7 as measured by CMIA
  • Occurrence of Adverse Events After Vaccination [ Time Frame: Within 7 days after the vaccination ]
    Occurrence of adverse reactions within 7 days after vaccination with the hepatitis
  • Anti-HBs Seroconversion Rate at month 12 [ Time Frame: Month 12 ]
    Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
  • Anti-HBs concentration at month 12 [ Time Frame: Month 12 ]
    Anti-HBs concentration at month 12 as measured by CMIA
  • Anti-HBs Seroconversion Rate at month 18 [ Time Frame: Month 18 ]
    Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
  • Anti-HBs concentration at month 18 [ Time Frame: Month 18 ]
    Anti-HBs concentration at month 18 as measured by CMIA
  • Anti-HBs Seroconversion Rate at month 30 [ Time Frame: Month 30 ]
    Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
  • Anti-HBs concentration at month 30 [ Time Frame: Month 30 ]
    Anti-HBs concentration at month 30 as measured by CMIA
  • Anti-HBs Seroconversion Rate at month 42 [ Time Frame: Month 42 ]
    Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
  • Anti-HBs concentration at month 42 [ Time Frame: Month 42 ]
    Anti-HBs concentration at month 42 as measured by CMIA
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients
Official Title  ICMJE A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in HIV-Infected Patients
Brief Summary

At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.

This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients
Detailed Description Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B Vaccine
Intervention  ICMJE
  • Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
    three-dose, 20 µg per dose
  • Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
    four-dose, 20 µg per dose
  • Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
    four-dose, 60 µg per dose
Study Arms  ICMJE
  • Experimental: 20 µg at months 0, 1, and 6
    20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
    Intervention: Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
  • Experimental: 20 µg at months 0, 1, 2,and 6
    20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
    Intervention: Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
  • Experimental: 60 µg at months 0, 1, 2,and 6
    60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
    Intervention: Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019) 		300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
  • Sign informed consent, willing to participate in this study

Exclusion Criteria:

  • Being pregnant
  • Intolerance or allergy to any component of the vaccine
  • Any vaccination during the month preceding enrollment
  • CD4 cell count ≤ 200 cells/µL
  • Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
  • The use of immunosuppressive agents in patients with nearly three months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Suping Wang, PhD #86-351-4135103 spwang88@163.com
Contact: Yongliang Feng, PhD #86-351-4135362 fengyongliang048@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962803
Other Study ID Numbers  ICMJE 2018ZX10721202001002001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Suping Wang, Shanxi Medical University
Study Sponsor  ICMJE Shanxi Medical University
Collaborators  ICMJE Centers for Disease Control and Prevention, China
Investigators  ICMJE
Principal Investigator: Suping Wang, PhD Shanxi Medical University
PRS Account Shanxi Medical University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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