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.
Abstract
Objective This study aimed to evaluate the immunoprotective effect of anti-rabies virus cocktail monoclonal antibody Zamerovimab/Mazorelvimab after rabies exposure.Methods The dynamic data of rabies virus neutralizing antibody(RVNA)were analyzed in the Zamerovimab/Mazorelvimab Chinese phase Ⅲ study(clinical trial registration number:CTR20201819).Results The full analysis set showed that RVNA geometric mean titers(GMT)on the 4th,8th,15th,43 rd,and 99th 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 4th,8th,15th,43rd,and 99th 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.Conclusions Compared 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.
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