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Hepat Mon. 2012 May;12(5):344-8. doi: 10.5812/hepatmon.6438. Epub 2012 May 30.

A randomized controlled trial of two schedules of hepatitis B vaccination in predialysed chronic renal failure patients.

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1
Nephrology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, IR Iran.

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.

KEYWORDS:

Hepatitis B; Kidney Failure, Chronic; Vaccination

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