Safety and immunogenicity of a new hepatitis B vaccine for the protection of patients with renal insufficiency including pre-haemodialysis and haemodialysis patients
Safety and immunogenicity of a new hepatitis B vaccine for the protection of patients with renal insufficiency including pre-haemodialysis and haemodialysis patients
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DOI：
10.1517/14712598.8.2.235
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发表时间：
2008-02-01
影响因子：
4.6
通讯作者：
Beran, Jiri
中科院分区：
文献类型：
--
作者：
Beran, Jiri
背景资料：对包括B型肝炎病毒（HBV）在内的感染的高度易感性导致终末期肾病患者的发病率和死亡率增加。建议所有接受透析的患者接种HBV疫苗;然而，抗体反应远低于健康个体。目的：本文综述了在透析患者中使用新型佐剂系统的HBV疫苗的临床经验。方法：一种新的含佐剂的HBV疫苗（Fendrix（TM），GlaxoSmithKline Biologicals，里克森萨尔，比利时）含有20 μ g在酿酒酵母中产生的重组B型肝炎表面抗原作为活性物质，以及由铝盐和3-O-脱酰基-4 ′-单磷酰脂质A（AS 04）组成的新佐剂系统。结论：HBV-AS 04疫苗具有良好的安全性特征，临床上可接受的反应与标准HBV疫苗相似，与四倍剂量的标准HBV疫苗相比，在透析前和血液透析患者中引起更早的抗体应答和更高的抗体滴度。
Background: High susceptibility to infections including the hepatitis B virus (HBV) causes increased morbidity and mortality in patients with end stage renal disease. HBV vaccination is recommended for all patients undergoing dialysis; however, antibody response is much lower than in healthy individuals. Objective: This review discusses the clinical experience with HBV vaccine with a novel adjuvant system among dialysed patients. Method: A new adjuvanted HBV vaccine (Fendrix (TM), GlaxoSmithKline Biologicals, Rixensart, Belgium) contains as active substance 20 mu g recombinant hepatitis B surface antigen produced in Saccharomyces cerevisiae and the novel adjuvant system composed of aluminum salt and 3-O-desacyl-4'-monophosphoryl lipid A (AS04). Conclusion: HBV-AS04 vaccine has a good safety profile with clinically acceptable reactions similar to standard HBV vaccines and has elicited earlier antibody response and higher antibody titres in pre and haemodialysis patients as compared with four double doses of standard HBV vaccine.