Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients

Study Overview
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Brief Summary
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Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled and this could improve seroconversion rate of hepatitis B vaccination. In this study, the investigators aimed to compare seroconversion rates and immune response rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B surface antigen (HBsAg) vaccine given to predialysis CKD patients.

Detailed Description
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In an open, randomized clinical trial, the investigators compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure using either 40 μg 4 doses or 20 μg 3 doses of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months respectively.

Official Title
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A Randomized Controlled Trial of Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients

Conditions
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Renal Failure

Intervention / Treatment
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* Biological: four doses of Euvax B vaccine
* Biological: 20 μg (1 ml) three doses of Euvax B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: predialysis patients, > 18 years with mild and moderate chronic renal failure, serum creatinine between 1.5-6 mg/dl Exclusion Criteria: patients with severe renal failure, serum creatinine > 6 mg/dl, requiring dialysis or expected to require dialysis within 1 year, receiving immunosuppressive treatment, known lymphoproliferative disorder.

Ages Eligible for Study
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Minimum Age: 25 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 40 μg (2 ml) four doses of Euvax B vaccine<br>40 μg (2 ml) four doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea) | Biological: four doses of Euvax B vaccine<br>* 40 μg (2 ml) four doses of Euvax B vaccine<br>* Other names: Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea);|
| Experimental: 20 μg (1 ml) three doses of Euvax B vaccine<br>20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea) | Biological: 20 μg (1 ml) three doses of Euvax B vaccine<br>* 20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis B surface antibody mIU/ml | Anti-HBs titres less than 10 mIU/ml were defined as non-seroconversion or non-responder. Anti-HBs titres greater than or equal to 10 mIU/ml but less than 100 mIU/ml were defined as seroconversion with low level antibody. Anti- HBs titres greater than or equal to100 mIU/ml were defined as seroconversion with protective levels of hepatitis B antibody. | 8-10 weeks after the 6-month dose of vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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predialysed, chronic, renal failure patients