泽美洛韦玛佐瑞韦单抗对狂犬病Ⅲ级暴露者狂犬病病毒中和抗体水平的影响  

Effects of Zamerovimab/Mazorelvimab on the rabies virus neutralizing antibody level in the gradeⅢrabies post exposure subjects

作　　者：王秀清 查永贤 王正雄 蒋娅 张象瑜 郭江书 李婧瑜 刘晓强[1] Wang Xiuqing;Zha Yongxian;Wang Zhengxiong;Jiang Ya;Zhang Xiangyu;Guo Jiangshu;Li Jingyu;Liu Xiaoqiang(Yunnan Provincial Center for Disease Control and Prevention,Kunming 650000,China;Yanshan County Center for Disease Control and Prevention,Yanshan 663100,China;Qiubei County Center for Disease Control and Prevention,Qiubei 663200,China;Mile Center for Disease Control and Prevention,Mile 652300,China;Gejiu Center for Disease Control and Prevention,Gejiu 661000,China;Kaiyuan Center for Disease Control and Prevention,Kaiyuan 661600,China)

机构地区：[1]云南省疾病预防控制中心疫苗临床研究中心,昆明650000 [2]砚山县疾病预防控制中心,砚山663100 [3]丘北县疾病预防控制中心,丘北663200 [4]弥勒市疾病预防控制中心,弥勒652300 [5]个旧市疾病预防控制中心,个旧661000 [6]开远市疾病预防控制中心,开远661600

出　　处：《中华实验和临床病毒学杂志》2024年第4期388-394,共7页Chinese Journal of Experimental and Clinical Virology

摘　　要：目的评价抗狂犬病病毒单克隆抗体(以下简称单抗)泽美洛韦玛佐瑞韦在狂犬病暴露后的免疫保护作用。方法分析泽美洛韦玛佐瑞韦单抗的中国Ⅲ期临床研究(临床试验注册号:CTR20201819)中受试者外周血狂犬病病毒中和抗体(rabies virus neutralizing antibody,RVNA)的动态变化数据。结果全分析集结果显示,泽美洛韦玛佐瑞韦单抗组第4、8、15、43、99天的RVNA几何平均滴度(geometric mean titer,GMT)分别为4.413 IU/ml、5.178 IU/ml、17.062 IU/ml、14.672 IU/ml、2.836 IU/ml,狂犬病人免疫球蛋白(human rabies immunoglobulin,HRIG)组分别为0.299 IU/ml、0.451 IU/ml、11.374 IU/ml、18.063 IU/ml、6.769 IU/ml;泽美洛韦玛佐瑞韦单抗组第4、8、15、43、99天的RVNA阳性率分别为99.9%、99.6%、100%、100%、97.4%,HRIG组分别为23.3%、34.1%、97.6%、99.6%、98.4%。结论与HRIG相比,泽美洛韦玛佐瑞韦单抗在给药后能快速达到机体所需的RVNA保护水平,从而有效发挥被动免疫制剂对狂犬病病毒的即刻中和作用。ObjectiveThis study aimed to evaluate the immunoprotective effect of anti-rabies virus cocktail monoclonal antibody Zamerovimab/Mazorelvimab after rabies exposure.MethodsThe dynamic data of rabies virus neutralizing antibody(RVNA)were analyzed in the Zamerovimab/Mazorelvimab Chinese phaseⅢstudy(clinical trial registration number:CTR20201819).ResultsThe full analysis set showed that RVNA geometric mean titers(GMT)on the 4 th,8 th,15 th,43 rd,and 99 th day in the Zamerovimab/Mazorelvimab group were 4.413 IU/ml,5.178 IU/ml,17.062 IU/ml,14.672 IU/ml,and 2.836 IU/ml,respectively,while those in the human rabies immunoglobulin(HRIG)group were 0.299 IU/ml,0.451 IU/ml,11.374 IU/ml,18.063 IU/ml,and 6.769 IU/ml,respectively.The positive rates of RVNA on the 4 th,8 th,15 th,43 rd,and 99 th day in the Zamerovimab/Mazorelvimab group were 99.9%,99.6%,100%,100%,and 97.4%,respectively,while those in the HRIG group were 23.3%,34.1%,97.6%,99.6%,and 98.4%,respectively.ConclusionsCompared with HRIG,Zamerovimab/Mazorelvimab cocktail monoclonal antibody reached the required protection level of RVNA very soon,thus effectively provided an immediate neutralizing effect of passive immunization therapies against rabies virus.

关 键 词：狂犬病 单克隆抗体 中和抗体 

分 类 号：R512.99[医药卫生—内科学]