Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
NCT ID: NCT03962816
Last Updated: 2019-05-24
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
300 participants
INTERVENTIONAL
2019-05-26
2023-12-31
Brief Summary
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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 Methadone Maintenance Treatment Patients
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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20 µg at months 0, 1, and 6
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
three-dose, 20 µg per dose
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
20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 20 µg per dose
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
60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 60 µg per dose
Interventions
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20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
three-dose, 20 µg per dose
20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 20 µg per dose
60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 60 µg per dose
Eligibility Criteria
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Inclusion Criteria
* Sign informed consent, willing to participate in this study
Exclusion Criteria
* Intolerance or allergy to any component of the vaccine
* Any vaccination during the month preceding enrollment
* Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
* Patient with HIV Infection
* The use of immunosuppressive agents in patients with nearly three months
20 Years
70 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention, China
OTHER_GOV
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
Locations
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Xinghualing Methadone Drug Point
Taiyuan, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Mo X, Men Z, Gao L, Gao Y, Yao T, Liu Y, Yuan Y, Xue T, Wang F, Wang S, Wang K, Liang X, Feng Y. Immunogenicity persistence after four intramuscular triple-dose or standard-dose hepatitis B vaccine in patients receiving methadone maintenance treatment: A 1-year follow-up study in China. Hum Vaccin Immunother. 2025 Dec;21(1):2447108. doi: 10.1080/21645515.2024.2447108. Epub 2025 Jan 17.
Feng Y, Yao T, Gao Y, Li H, Dong S, Wu Y, Liu Y, Li J, Liu C, Liu J, Xue T, Yuan Y, Wu J, Wang F, Liang X, Wang S. Immunogenicity, safety, and compliance of high- and standard-strength four-dose hepatitis B vaccination regimens in patients receiving methadone maintenance therapy in China: a randomized, parallel-arm controlled trial. Expert Rev Vaccines. 2021 Dec;20(12):1629-1635. doi: 10.1080/14760584.2021.1977629. Epub 2021 Sep 16.
Other Identifiers
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2018ZX10721202001002002
Identifier Type: -
Identifier Source: org_study_id
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