Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
NCT ID: NCT02991599
Last Updated: 2021-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
196 participants
INTERVENTIONAL
2014-10-31
2018-05-31
Brief Summary
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Detailed Description
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Intervention:
Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;
Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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60 µg dose hepatitis B vaccine
60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose
20 µg dose hepatitis B vaccine
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose
Interventions
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60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose
20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose
Eligibility Criteria
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Inclusion Criteria
* 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
* Intolerance or allergy to any component of the vaccine
* Any vaccination during the month preceding enrollment
* Ongoing opportunistic infection
* Liver disease
* Hematological disorder
* Cancer
* Unexplained fever the week before enrollment
18 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
Role: PRINCIPAL_INVESTIGATOR
Shanxi Medical University
References
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Shi J, Feng Y, Gao L, Feng D, Yao T, Shi S, Zhang Y, Liang X, Wang S. Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial. Vaccine. 2017 Apr 25;35(18):2443-2448. doi: 10.1016/j.vaccine.2017.03.034. Epub 2017 Mar 23.
Other Identifiers
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2012ZX10002001003004003
Identifier Type: -
Identifier Source: org_study_id