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新型第三代重组乙型肝炎疫苗在终末期肾病患者中的免疫原性改善

Improved immunogenicity of a novel third-generation recombinant hepatitis B vaccine in patients with end-stage renal disease.

作者信息

Weinstein Talia, Chagnac Avry, Boaz Mona, Ori Yaacov, Herman Michal, Zevin Dina, Schmilovitz-Weiss Hemda, Gafter Uzi

机构信息

Department of Nephrology, Rabin Medical Center-Campus Golda, Petach-Tikva, Israel.

出版信息

Nephron Clin Pract. 2004;97(2):c67-72. doi: 10.1159/000078403.

DOI:10.1159/000078403
PMID:15218332
Abstract

Hepatitis B (HBV) infection remains a significant epidemiological problem in the end-stage renal disease (ESRD) population. Vaccination programs using second-generation vaccines lead to effective seroprotection in only 50-60% of these patients. The purpose of this case series was to describe our experience with a novel third-generation vaccine, Bio-Hep-B, in ESRD patients who had not developed protective anti-HBs titers following a second-generation HBV vaccination protocol. Twenty-nine ESRD patients who had not responded in the past to a standard second-generation HBV vaccination protocol were included in this series. Each patient received 10 microg of Bio-Hep-B) intramuscularly at 0, 1 and 6 months. A month after completion of the vaccination protocol, anti-HBs antibody levels were measured. Following immunization, 25 of 29 patients (86%) developed seroprotective anti-HBs levels > or =10 mIU/ml. There was a significant difference in the titers of anti-HBs antibodies prior to and following vaccination (p < 0.0001). Statistical analysis of the variables age, gender, diagnosis, dialysis mode, weight, hemoglobin, albumin, and KT/V failed to detect predictors of antibody response. A retrospective analysis of the results of a second-generation vaccination program for the years 1999-2001 in our department showed that 19 of 36 (56.4%) ESRD patients developed seroprotection. In conclusion, the results of this study show that the third-generation HBV vaccine Bio-Hep-B is highly immunogenic in the population of ESRD patients who did not respond in the past to a second-generation vaccine. This enhanced seroprotection offers hope that the new vaccine will reduce the rate of non-responders and help to eliminate HBV infection from dialysis centers.

摘要

乙型肝炎(HBV)感染在终末期肾病(ESRD)人群中仍然是一个严重的流行病学问题。使用第二代疫苗的免疫接种计划仅能使50%至60%的此类患者获得有效的血清保护。本病例系列的目的是描述我们在ESRD患者中使用新型第三代疫苗Bio-Hep-B的经验,这些患者在遵循第二代HBV疫苗接种方案后未产生保护性抗-HBs滴度。本系列纳入了29例过去对标准第二代HBV疫苗接种方案无反应的ESRD患者。每位患者在0、1和6个月时肌肉注射10微克Bio-Hep-B。在完成疫苗接种方案一个月后,检测抗-HBs抗体水平。免疫接种后,29例患者中有25例(86%)产生了血清保护性抗-HBs水平≥10 mIU/ml。接种疫苗前后抗-HBs抗体滴度存在显著差异(p<0.0001)。对年龄、性别、诊断、透析方式、体重、血红蛋白、白蛋白和KT/V等变量进行统计分析,未发现抗体反应的预测因素。对我们科室1999 - 2001年第二代疫苗接种计划结果的回顾性分析显示,36例ESRD患者中有19例(56.4%)产生了血清保护。总之,本研究结果表明,第三代HBV疫苗Bio-Hep-B在过去对第二代疫苗无反应的ESRD患者群体中具有高度免疫原性。这种增强的血清保护为新疫苗降低无反应率并有助于消除透析中心的HBV感染带来了希望。

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