Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients
NCT ID: NCT03962803
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
2019-06-05
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 HIV-Infected 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
* 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
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, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanxi Medical University
Locations
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Shanxi Center for Disease Control and Prevention
Taiyuan, , China
Countries
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Central Contacts
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References
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Feng Y, Chen Z, Xie R, Yao T, Wu Y, Yang F, Yuan C, Nie X, Wang F, Liang X, Wang S. Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2022 Jun;21(6):861-868. doi: 10.1080/14760584.2022.2056024. Epub 2022 Apr 1.
Other Identifiers
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2018ZX10721202001002001
Identifier Type: -
Identifier Source: org_study_id
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