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

Not Applicable

Completed

• Conditions: Renal Failure
• Interventions: Biological: four doses of Euvax B vaccine; Biological: 20 μg (1 ml) three doses of Euvax B vaccine

• Registration Number: NCT01468051
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2011-10-27
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-08
• Last Update Submitted: 2011-11-08
• Study First Posted: 2011-11-09
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40 μg (2 ml) four doses of Euvax B vaccine	four doses of Euvax B vaccine	40 μg (2 ml) four doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
20 μg (1 ml) three doses of Euvax B vaccine	20 μg (1 ml) three doses of Euvax B vaccine	20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)

Primary Outcome Measures

Name	Time	Method
Hepatitis B surface antibody mIU/ml	8-10 weeks after the 6-month dose of vaccine	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.