NCT01468051

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Failure

Interventions

Type	Name	Description
BIOLOGICAL	four doses of Euvax B vaccine	40 μg (2 ml) four doses of Euvax B vaccine
BIOLOGICAL	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)

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2011-11-09
• Last updated: 2011-11-09