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目的:评价维持性血液透析（MHD）患者接种重组戊型肝炎疫苗的安全性和免疫原性。方法:采用开放对照试验法，于2016年5月至2018年3月在厦门大学附属中山医院血液透析中心招募35例符合标准的MHD患者为试验组，70例年龄、性别、基础疾病与试验组匹配的MHD患者为对照组。试验组按照标准接种程序分别于第0、1、6 月接种戊型肝炎疫苗，对照组常规诊疗，未给予疫苗及安慰剂注射。通过试验组和对照组对象的不良反应/事件发生率，评价疫苗在MHD中的安全性；通过比较全程接种戊肝疫苗MHD患者与Ⅲ期临床试验数据，评价疫苗在MHD中的免疫原性。结果:总体不良反应/事件发生率为17.1%（18/105），未出现与疫苗接种相关的3、4级不良反应/事件。试验组局部不良反应/事件发生率为20.0%（7/35），全身不良反应/事件发生率为17.1%（6/35）；试验组与对照组全身不良反应/事件发生率相比差异无统计学意义（n P>0.05）。23名全程接种者接种后的HEV-IgG抗体阳性率为100%，GMC为14.47（95%n CI：13.14~15.80）WU/ml，与46名Ⅲ期临床试验对象接种后的抗体滴度［GMC为18.08（95%n CI：13.63~22.54）WU/ml］差异无统计学意义（n t=-1.04，n P>0.05）。n 结论:重组戊型肝炎疫苗在MHD患者中安全性和免疫原性均较好。“,”Objective:To evaluate the safety and immunogenicity of hepatitis E vaccine(HEV)in Maintenance hemodialysis(MHD)patients.Methods:Based on an open-labeled controlled trial, from May 2016 to March 2018, 35 eligible MHD patients were recruited in the Hemodialysis Center of Zhongshan Hospital Affiliated to Xiamen University as the experimental group, and 70 MHD patients with matched age, gender and underlying diseases as the control group. The experimental group received HEV at 0, 1 and 6 months according to the standard vaccination procedures, while the control group received routine diagnosis and treatment without vaccine and placebo injection to observe the safety and immunogenicity of the vaccine. The safety of vaccine in MHD population was evaluated by the incidence of adverse reactions/events in the experimental and control groups. The immunogenicity of HEV in MHD patients was evaluated by comparing the data from the phase Ⅲ clinical trial.Results:The overall incidence of adverse reactions/events was 17.1% (18/105), and there were no grade 3-4 adverse reactions/events related to vaccination. In the experimental group, the incidence of local adverse reactions/events was 20.0% (7/35), and the incidence of systemic adverse reactions/events was 17.1% (6/35).There was no significant difference in the incidence of systemic adverse reactions/events between the experimental group and the control group (n P>0.05). There were 23 patients receiving 3 doses with the standard schedule. The positive rate of HEV-IgG antibody was 100% and the GMC was 14.47(95%n CI:13.14-15.80) WU/ml, which showed no significant difference compared with the 46 patients in Phase Ⅲ clinical trial (n t=-1.04, n P>0.05).n Conclusion:Recombinant HEV has good safety and immunogenicity in MHD patients.