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临床试验/IRCT138805122276N1
IRCT138805122276N1已完成未知

Comparison of efficacy between intramuscular and intradermal injection of Hepatitis B vaccine in Buali Sina dialysis centre, Qazvin.

Qazvin University of Medical Sciences0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
40

研究概览

简要总结

Background: Low immunogenicity of hepatitis B vaccine is an important problem in patients with chronic renal failure (CRF). A possible solution is intradermal versus conventional intramuscular delivery of vaccine in this population. The goal of this study was to compare the efficacy of these routes of vaccination in Bu-alicina Dialysis Center, Qazvin, Iran. Materials and Methods: This randomized clinical trial was done on 29 CRF non-responders randomly allocated to two groups. Fifteen patients received 40 µg of euvax B vaccine intradermally and 14 patients received 160 µg of this vaccine intramuscularly. Anti-HBs antibody titre was measured after 1, 6, and 12 months. Seroprotection was defined as anti-HBs antibody titre above 10 lU/L. Data were analyzed using SPSS software version 16. Results: Difference of seroprotection rate between two groups was not statistically significant after1and 6 months; however, after 12 months, seroprotection rate was 93.3% in the interadermal group versus 50% in the intramuscular group (p

研究设计

研究类型
Interventional

入排标准

年龄范围
14 years 至 no limit(—)
性别
All

入选标准

  • CRF patients who are under dialysis (hemodyalisis or peritoneal dialysis) in Bualisina dialysis centre, HBsAg lower than 10 U/ml and at least a previous course of hepatitis B vaccination.
  • Exclusion criteria: Presence of malignancy, severe malnutrition, positive HBsAg, kidney transplantation, immunocompromising disease such as AIDS.

排除标准

  • 未提供

研究者

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