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The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students

Primary Purpose

Hepatitis B Vaccine

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
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, Booster Dose, Long-term Immune Response, College Students

Eligibility Criteria

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

Inclusion Criteria:

  • Aged of 18 years or above
  • Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) at enrollment
  • Sign informed consent, willing to participate in this study

Exclusion Criteria:

  • Being pregnant
  • Intolerance or allergy to any component of the vaccine
  • Participants with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    20 µg at month 0, months 0, 1 or 0, 1, and 6

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Anti-HBs Seroconversion Rate at Months 1
    Anti-HBs Seroconversion Rate at Months 1
    Anti-HBs Seroconversion Rate at Months 3
    Anti-HBs Seroconversion Rate at Months 3
    Anti-HBs Seroconversion Rate at Months 7
    Anti-HBs Seroconversion Rate at Months 7
    Anti-HBs Seroconversion Rate at Months 12
    Anti-HBs Seroconversion Rate at Months 12
    Anti-HBs Seroconversion Rate at Months 18
    Anti-HBs Seroconversion Rate at Months 18
    Anti-HBs Seroconversion Rate at Months 24
    Anti-HBs Seroconversion Rate at Months 24
    Anti-HBs Seroconversion Rate at Months 30
    Anti-HBs Seroconversion Rate at Months 30

    Secondary Outcome Measures

    Anti-HBs Concentration at Months 1
    Anti-HBs Concentration at Months 1
    Anti-HBs Concentration at Months 3
    Anti-HBs Concentration at Months 3
    Anti-HBs Concentration at Months 7
    Anti-HBs Concentration at Months 7
    Anti-HBs Concentration at Months 12
    Anti-HBs Concentration at Months 12
    Anti-HBs Concentration at Months 18
    Anti-HBs Concentration at Months 18
    Anti-HBs Concentration at Months 24
    Anti-HBs Concentration at Months 24
    Anti-HBs Concentration at Months 30
    Anti-HBs Concentration at Months 30

    Full Information

    First Posted
    October 13, 2021
    Last Updated
    December 2, 2021
    Sponsor
    Shanxi Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05099757
    Brief Title
    The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
    Official Title
    The Study on the Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2022 (Anticipated)
    Primary Completion Date
    November 25, 2022 (Anticipated)
    Study Completion Date
    December 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanxi Medical University

    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
    The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. It is necessary to study the anti-HBs level of college students, and analyze the strengthening immunization for this special group. This study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis B vaccines. Different booster vaccination including one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) was given according to the antibody production level after booster vaccination among college students.
    Detailed Description
    Participants are given booster dose of one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) 20 µg recombinant hepatitis B vaccine according to the antibody production level. 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, Immunogenicity, Booster Dose, Long-term Immune Response, College Students

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    20 µg at month 0, months 0, 1 or 0, 1, and 6
    Arm Type
    Experimental
    Arm Description
    20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6
    Intervention Type
    Biological
    Intervention Name(s)
    20 µg dose hepatitis B vaccine
    Intervention Description
    one-dose, two-dose or three-dose, 20 µg per dose
    Primary Outcome Measure Information:
    Title
    Anti-HBs Seroconversion Rate at Months 1
    Description
    Anti-HBs Seroconversion Rate at Months 1
    Time Frame
    Months 1
    Title
    Anti-HBs Seroconversion Rate at Months 3
    Description
    Anti-HBs Seroconversion Rate at Months 3
    Time Frame
    Months 3
    Title
    Anti-HBs Seroconversion Rate at Months 7
    Description
    Anti-HBs Seroconversion Rate at Months 7
    Time Frame
    Months 7
    Title
    Anti-HBs Seroconversion Rate at Months 12
    Description
    Anti-HBs Seroconversion Rate at Months 12
    Time Frame
    Months 12
    Title
    Anti-HBs Seroconversion Rate at Months 18
    Description
    Anti-HBs Seroconversion Rate at Months 18
    Time Frame
    Months 18
    Title
    Anti-HBs Seroconversion Rate at Months 24
    Description
    Anti-HBs Seroconversion Rate at Months 24
    Time Frame
    Months 24
    Title
    Anti-HBs Seroconversion Rate at Months 30
    Description
    Anti-HBs Seroconversion Rate at Months 30
    Time Frame
    Months 30
    Secondary Outcome Measure Information:
    Title
    Anti-HBs Concentration at Months 1
    Description
    Anti-HBs Concentration at Months 1
    Time Frame
    Months 1
    Title
    Anti-HBs Concentration at Months 3
    Description
    Anti-HBs Concentration at Months 3
    Time Frame
    Months 3
    Title
    Anti-HBs Concentration at Months 7
    Description
    Anti-HBs Concentration at Months 7
    Time Frame
    Months 7
    Title
    Anti-HBs Concentration at Months 12
    Description
    Anti-HBs Concentration at Months 12
    Time Frame
    Months 12
    Title
    Anti-HBs Concentration at Months 18
    Description
    Anti-HBs Concentration at Months 18
    Time Frame
    Months 18
    Title
    Anti-HBs Concentration at Months 24
    Description
    Anti-HBs Concentration at Months 24
    Time Frame
    Months 24
    Title
    Anti-HBs Concentration at Months 30
    Description
    Anti-HBs Concentration at Months 30
    Time Frame
    Months 30
    Other Pre-specified Outcome Measures:
    Title
    Occurrence of Adverse Events After Vaccination
    Description
    Occurrence of Adverse Events After Vaccination
    Time Frame
    Within 7 days after the vaccination
    Title
    Occurrence of Adverse Events After Vaccination
    Description
    Occurrence of Adverse Events After Vaccination
    Time Frame
    Within 28 days after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged of 18 years or above Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) at enrollment Sign informed consent, willing to participate in this study Exclusion Criteria: Being pregnant Intolerance or allergy to any component of the vaccine Participants with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suping Wang, PhD
    Phone
    +86-351-4135103
    Email
    supingwang@sxmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suping Wang, PhD
    Organizational Affiliation
    Shanxi Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students

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