Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population

Conditions
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Hepatitis B Vaccine

Intervention / Treatment
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* Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
* Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
* Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 70 years at the enrolment Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment Sign informed consent, willing to participate in this study Exclusion Criteria: Being pregnant 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 Patients with Hepatitis B virus associated glomerulone nephritis or HBV DNA Positive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 µg at months 0, 1, and 6<br>20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 | Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6<br>* three-dose, 20 µg per dose<br>|
| Experimental: 20 µg at months 0, 1, 2,and 6<br>20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6 | Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6<br>* four-dose, 20 µg per dose<br>|
| Experimental: 60 µg at months 0, 1, 2,and 6<br>60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6 | Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6<br>* four-dose, 60 µg per dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs Seroconversion Rate at Month 7 | Anti-HBs Seroconversion Rate at month 7 as measured by CMIA | Month 7 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Vaccine, Randomized Controlled Trial, Chronic Kidney Disease Population, Immunogenicity, Long-term Immune Response