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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention, China | OTHER_GOV |
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At present, chronic kidney disease population are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.
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 chronic kidney disease population.
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 µg at months 0, 1, and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
|
| 20 µg at months 0, 1, 2,and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6 |
|
| 60 µg at months 0, 1, 2,and 6 | Experimental | 60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 | Biological | three-dose, 20 µg per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs Seroconversion Rate at Month 7 | Anti-HBs Seroconversion Rate at month 7 as measured by CMIA | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs concentration at month 7 | Anti-HBs concentration at month 7 as measured by CMIA | Month 7 |
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongliang Feng, PhD | Contact | #86-351-4135362 | fengyongliang048@163.com | |
| Suping Wang, PhD | Contact | #86-351-4135103 | spwang88@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongliang Feng, PhD | Shanxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Central Hospital of Linfen | Linfen | China | ||||
| The People's Hospital of Linfen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39378326 | Derived | Yao T, Li Y, Zhang Y, Sun Y, Guo Y, Wang J, Song X, Zhang W, Wei B, Bai J, Wang H, Yu W, Wang H, Jiao L, Diao Y, Liu L, Shi S, Yang J, Ren X, Liu W, Fang J, Liang X, Wang S, Feng Y. Immunogenicity, Safety, and Persistence Induced by Triple- and Standard-Strength 4-Dose Hepatitis B Vaccination Regimens in Patients Receiving Hemodialysis. J Infect Dis. 2025 Apr 15;231(4):1049-1059. doi: 10.1093/infdis/jiae494. | |
| 35968570 |
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| 20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6 | Biological | four-dose, 20 µg per dose |
|
| 60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6 | Biological | four-dose, 60 µg per dose |
|
| Within 7 days after the vaccination |
| Anti-HBs Seroconversion Rate at Month 12 | Anti-HBs Seroconversion Rate at month 12 as measured by CMIA | Month 12 |
| Anti-HBs Concentration at Month 12 | Anti-HBs Concentration at Month 12 as measured by CMIA | Month 12 |
| Anti-HBs Seroconversion Rate at Month 18 | Anti-HBs Seroconversion Rate at month 18 as measured by CMIA | Month 18 |
| Anti-HBs Concentration at Month 18 | Anti-HBs Concentration at Month 18 as measured by CMIA | Month 18 |
| Anti-HBs Seroconversion Rate at Month 30 | Anti-HBs Seroconversion Rate at month 30 as measured by CMIA | Month 30 |
| Anti-HBs Concentration at Month 30 | Anti-HBs Concentration at Month 30 as measured by CMIA | Month 30 |
| Anti-HBs Seroconversion Rate at Month 42 | Anti-HBs Seroconversion Rate at month 42 as measured by CMIA | Month 42 |
| Anti-HBs Concentration at Month 42 | Anti-HBs Concentration at Month 42 as measured by CMIA | Month 42 |
| Linfen |
| China |
| Derived |
| Han Y, Cao N, Lu X, Yao T, Shi J, Wu Y, Dong S, Shao Z, Wang J, Liu H, Guo H, Chai G, Liu L, Wang F, Feng Y, Liang X, Wang S. Duration of immunogenicity of high-dose and prolonged-schedule hepatitis B vaccine among patients with chronic kidney disease: A one year follow-up study in China. Expert Rev Vaccines. 2022 Nov;21(11):1675-1682. doi: 10.1080/14760584.2022.2112951. Epub 2022 Aug 18. |
| 34058948 | Derived | Feng Y, Yao T, Han Y, Shi J, Dong S, Wu Y, Shao Z, Liu H, Guo H, Chai G, Liu L, Wang F, Wang J, Liang X, Wang S. Immunogenicity and safety of a high-dose and prolonged-schedule hepatitis B vaccine among chronic kidney disease patients: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2021 Jun;20(6):743-751. doi: 10.1080/14760584.2021.1915777. Epub 2021 May 31. |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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