The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
NCT ID: NCT05099757
Last Updated: 2021-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2022-02-20
2023-12-15
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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20 µg at month 0, months 0, 1 or 0, 1, and 6
20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6
20 µg dose hepatitis B vaccine
one-dose, two-dose or three-dose, 20 µg per dose
Interventions
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20 µg dose hepatitis B vaccine
one-dose, two-dose or three-dose, 20 µg per dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Shanxi Medical University
OTHER
Responsible Party
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Suping Wang
Professor
Principal Investigators
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Suping Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanxi Medical University
Central Contacts
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Other Identifiers
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DXSHB20211012
Identifier Type: -
Identifier Source: org_study_id