Abstract

Hepatitis B (HB) may progress to cirrhosis and liver carcinoma. Its prevalence is estimated at 3.2 % in hemodialysis (HD) patients. HB vaccine when applied intramuscularly (IM) in end-stage renal disease patients often does not induce appropriate antibody titers. However, there has been suggestion for intradermal (ID) to be a more effective inoculation method. To compare the immune response to IM or ID vaccine administration on HD patients. Thirty one incident HD patients were randomly assigned alternately to IM or ID vaccine inoculation. Vaccine doses were applied at three monthly intervals, with patients being followed-up for six months. Sixteen patients were assigned to IM (40 mg/dose) and 15 to ID (4 mg/dose) vaccine administration. HB-virus surface antibody titer, hematimetric parameters, serum urea level and Kt/V were monthly evaluated. C-reactive protein, parathormone, ferritin, aminotransferases and albumin serum levels were evaluated before and at the sixth month of the initial inoculation. Urea levels were significantly higher in the ID group (P(1) = 0.031); ferritin levels were higher in the IM (P(2) = 0.037) and C-reactive protein levels tended to be higher in the ID group. An interim evaluation by the Safety Monitoring Committee recommended discontinuing the study as IM vaccination had converted 62.5% of the exposed subjects, while ID inoculation converted only 13.3%. As performed, ID applied vaccine was inferior to the IM inoculation. Such result may depend on the inoculated doses or some other factor, such as inflammation.

Highlights

  • Carlos Abaeté de los Santos[1] Regina H Medeiros[1] Ana Elizabeth PL Figueiredo[1] Carlos Eduardo Polide-Figueiredo[1] Domingos Otávio d’Avila[1] Jaqueline Antonio Pacheco[1] Carlos Abaeté de los Santos[1]

  • The preferential route for hepatitis B (HB) vaccine administration remains controversial in hemodialysis (HD) patients

  • Our study aiming to compare intramuscular (IM) or intradermal (ID) inoculations was discontinued six months after starting, due to a Safety Monitoring Committee recommendation, since IM vaccination converted 62.3% of the patients, whereas the ID only 13.3%

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Summary

Introduction

Carlos Abaeté de los Santos[1] Regina H Medeiros[1] Ana Elizabeth PL Figueiredo[1] Carlos Eduardo Polide-Figueiredo[1] Domingos Otávio d’Avila[1] Jaqueline Antonio Pacheco[1] Carlos Abaeté de los Santos[1]. 1 Faculdade de Medicina da Pontifícia Universidade Católica do Rio Grande do Sul (PUC/RS).

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