一种国产人用狂犬病疫苗(Vero细胞)的免疫原性与安全性评价  

Safety and immunogenicity of a China-made rabies vaccine(vero-cell) for human use

作　　者：王文娟[1] 胡月梅[1] 胡传强[2] 张巍 戴启刚[1] 胡家垒[1] 唐蓉[1] 梁祁[1] 

机构地区：[1]江苏省疾病预防控制中心,江苏南京210009 [2]江苏省新沂市疾病预防控制中心,江苏新沂221400 [3]长春卫尔赛生物药业有限公司,吉林长春130616

出　　处：《现代预防医学》2016年第11期2079-2082,2087,共5页Modern Preventive Medicine

摘　　要：目的评价一种国产人用狂犬病疫苗（Vero细胞）用于10-60岁健康人群的免疫原性和安全性。方法单中心、随机、双盲、同类制品平行对照、模拟暴露后免疫的非劣效性研究。采用＂Essen＂免疫程序,选择10-60岁健康人群,按照1∶1比例随机接种试验疫苗和对照疫苗,使用日记卡收集每针次接种后不良反应情况。采集免前、首针免后第14天和第42天血液标本,用快速荧光灶抑制试验（RFFIT）检测血清中狂犬病毒中和抗体水平。结果试验组和对照组各入组600人。首针免后第42天和第14天,抗体阳转率均达到100%;抗体几何平均浓度（GMC）试验组为13.00IU/ml和7.89IU/ml,对照组为15.03IU/ml和10.20IU/ml,差异有统计学意义。总体征集性不良反应发生率试验组和对照组分别为60.33%和65.67%,差异无统计学意义。总体全身不良反应发生率对照组（46.17%）高于试验组（39.83%）,前3针次不良反应发生率对照组（25.17%、16.13%、27.97%）均高于试验组（17.83%、11.80%、22.24%）,差异有统计学意义。结论长春卫尔赛生物药业有限公司研制的人用狂犬病疫苗（Vero细胞）在10-60岁健康人群中具有较好的免疫原性和安全性。Objective To evaluate the immunogenicity and safety of a China-made rabies vaccine（Vero cell） for human use in healthy people aged 10-60 years.Methods A single-center,randomized,double-blind,positive-controlled,non-inferiority trial was conducted,simulating post-exposure rabies prophylaxis.Subjects were randomly inoculated with one of two rabies vaccines by 1：1 according to ＂Essen＂schedule.Adverse reactions/events were recorded with diary cards after each dose.Blood samples were collected on day 14 and 42 after the first dose.Immunogenicity was assessed by rapid fluorescence focus inhibition test（RFFIT）.Results 600 subjects were enrolled in each group.On day 42 and 14,both antibody positive conversion rates were 100%.Geometric Mean Concentrations（GMCs） of trial group were 13.00 IU/ml and 7.89 IU/ml while those of control group were 15.03 IU/ml and 10.20 IU/ml respectively.These differences were statistically significant.General adverse reaction rates were 60.33% and 65.67% without significant difference.General systemic reaction rate of the control group（46.17%） was higher than that of the trial group（39.83%）.The same thing happened when adverse reaction rates after each inoculation of the first three doses in the control group（25.17%,16.13%,27.97%） were compared with those of trial group（17.83%,11.80%,22.24%）.These differences were statistically significant.Conclusion The rabies vaccine（Vero cell） produced by Changchun Werersai Biotec Pharmaceutical Co.Ltd.showed good immunogenicity and safety.

关 键 词：人用狂犬病疫苗 VERO细胞 免疫原性 安全性 

分 类 号：R186.3[医药卫生—流行病学]