Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

Study Overview
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Brief Summary
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Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge. This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.

Detailed Description
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Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Official Title
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Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial

Conditions
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Hepatitis B Vaccine

Intervention / Treatment
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* Biological: 60 µg dose hepatitis B vaccine
* Biological: 20 µg dose hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having end-stage renal disease (ESRD) on maintenance hemodialysis Aged between 18 and 70 years at enrollment 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: Being pregnant Acute cytolysis in the last three months before enrollment Any vaccination during the month preceding enrollment Intolerance or allergy to any component of the vaccine Ongoing opportunistic infection Hepatitis C virus infection Hematological disorder Cancer Unexplained fever the week before enrollment Immunosuppressive or immunomodulating treatment in the last six months Renal transplantation or upcoming renal transplantation Liver disease Other immunocompromised condition not related to ESRD An expected survival of < 6 months

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: 60 µg dose hepatitis B vaccine<br>60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 | Biological: 60 µg dose hepatitis B vaccine<br>* three-dose, 60 µg per dose<br>|
| Experimental: 20 µg dose hepatitis B vaccine<br>20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 | Biological: 20 µg dose hepatitis B vaccine<br>* three-dose, 20 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 |  | Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs Seroconversion Rate at Month 42 |  | Month 42 | 
| Anti-HBs Seroconversion Rate at Month 36 |  | Month 36 | 
| Anti-HBs Seroconversion Rate at Month 30 |  | Month 30 | 
| Anti-HBs Seroconversion Rate at Month 24 |  | Month 24 | 
| Anti-HBs Concentration at Month 7 | Anti-HBs concentration at month 7 as measured by CMIA | Month 7 | 
| Anti-HBs Concentration at Month 12 | Anti-HBs concentration at month 12 as measured by CMIA | Month 12 | 
| Anti-HBs Seroconversion Rate at Month 12 |  | Month 12 | 
| 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 | 
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine | Within 28 days after the vaccination | 
| Anti-HBs Seroconversion Rate at Month 18 |  | Month 18 | 

 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, Hemodialysis, Immunogenicity