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

Abstract

Background: Patients with chronic renal disease should be vaccinated as soon as dialysis is forestalled, and this could improve the seroconversion of hepatitis B vaccination.Objectives: In this study, we aimed to compare seroconversion and immune response rates using 4 doses of 40 μg and 3 doses of 20 μg Euvax B recombinant Hepatitis B surface Antigen (HBs Ag) vaccine administered to predialysis patients with chronic kidney disease (CKD).Patients and Methods: In an open, randomized clinical trial, we compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure who received either 4 doses of 40 μg or 3 doses of 20 μg of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months, respectively.Results: Differences in seroconversion rates after 4 doses of 40 μg (80.88%) compared to 3 doses of 20 μg (92%) were not significant (P = 0.4124). The mean HBs antibody level after 4 doses of 40 μg at 0, 1, 2, and 6 months (182.2 ± 286.7) was significantly higher than that after 3 doses of 40 μg at 0,1, and 6 months (96.9 ± 192.1) (P = 0.004). Seroconversion after 4 doses of 40 μg (80.8%) was also significantly higher than that after 3 doses of 40 μg (77%) (P = 0.004). Multivariable analysis showed that none of the variables contributed to seroconversion.Conclusions: We found that 4 doses of 40 μg did not lead to significantly more seroconversion than 3 doses of 20 μg.

Implication for health policy/practice/research/medical education:This article presents Hepatitis B Vaccination in Patients with chronic renal disease.Please cite this paper as:Ahmadi F, Ramezani M, Razeghi E, Ranjbarnovin N, Khazaeipour Z. A randomized Controlled Trial of Two Schedules of Hepatitis B Vaccination in Predialysed Chronic Renal Failure Patients. Hepat Mon. 2012;12(5): 344-8. DOI: 10.5812/hepatmon.6438NCT registration identifier:NCT01468051 Copyright © 2012 Kowsar Corp. All rights reserved.