冻干人用狂犬病疫苗(Vero细胞)上市后在≥18岁人群中暴露前免疫接种的安全性及免疫原性  

Safety and immunogenicity of pre-exposure prophylaxis of approved freeze-dried rabies vaccine(Vero cell)for human use in adults≥18 years of age

作　　者：肖艳慧 郭雪 王圣怡 张锐智[3] 常少英[4] 杨渊 孙宏亮 陈霄 管庆虎[3] 姜崴 王慧[4] 顾建阳 罗林云 杨晓明 XIAO Yanhui;GUO Xue;WANG Shengyi;ZHANG Ruizhi;CHANG Shaoying;YANG Yuan;SUN Hongliang;CHEN Xiao;GUAN Qinghu;JIANG Wei;WANG Hui;GU Jianyang;LUO Linyun;YANG Xiaoming(China National Biotec Group Company Limited,Beijing 100024,China;不详)

机构地区：[1]中国生物技术股份有限公司,北京100024 [2]长春生物制品研究所有限责任公司,吉林长春130012 [3]贵州省疾病预防控制中心,贵州贵阳550004 [4]山西省疾病预防控制中心,山西太原030012

出　　处：《中国生物制品学杂志》2023年第11期1329-1334,共6页Chinese Journal of Biologicals

基　　金：吉林省科技发展计划(20210401063YY)。

摘　　要：目的评价冻干人用狂犬病疫苗(Vero细胞)(简称狂犬病疫苗)上市后在≥18岁人群中暴露前免疫接种的安全性及免疫原性。方法2022年6—9月选择贵州省和山西省≥18岁人群作为研究对象。受试者分别按0、7、28 d各接种1剂狂犬病疫苗,于第1剂疫苗接种前及接种第3剂后14 d静脉采血5.0 mL。采用免疫荧光灶试验进行狂犬病病毒中和抗体检测,收集每剂疫苗接种后0~7 d不良事件。结果共120人完成入组,其中120人完成第1剂狂犬病疫苗接种,119人完成第2剂狂犬病疫苗接种,118人完成第3剂狂犬病疫苗接种。局部不良事件症状以疼痛为主,全身不良事件症状以发热、疲劳/乏力、头晕、关节痛、腹泻为主。接种第1剂狂犬病疫苗前抗体阳性率为2.54%,抗体几何平均浓度(geometric mean concentration,GMC)为0.40 IU/mL。完成3剂疫苗接种后,抗体阳性率和阳转率均为100%,抗体GMC为9.68 IU/mL,抗体几何平均增长倍数(geometric mean increase,GMI)为23.99。接种第1、2、3剂狂犬病疫苗0~7 d的不良事件发生率分别为22.50%、13.45%和4.24%。结论狂犬病疫苗上市后在≥18岁人群中开展暴露前免疫具有良好的安全性及免疫原性。Objective To evaluate the safety and immunogenicity of pre-exposure prophylaxis of the approved freeze-dried rabies vaccine(Vero cell)(rabies vaccine in brief)for human use in adults≥18 years of age.Methods Participants aged≥18 years in Guizhou and Shanxi provinces from June 2022 to September 2022 were enrolled,vaccinated with 1 dose of rabies vaccine at 0,7,28 d respectively,and collected for 5.0 mL of venous blood before the first dose and 14 d after the third dose.Immunofluorescence foci assay was used to detect rabies virus neutralizing antibodies,and adverse events were collected 0~7 d after each dose of vaccine.Results A total of 120 participants were enrolled,120 participants received the first dose of rabies vaccine,119 participants received the second dose and 118 participants received the third dose.Before the first dose of rabies vaccine,the seropositive rate of antibody was 2.54%and the geometric mean concentration(GMC)was 0.40 IU/mL.After the third dose of rabies vaccine,the seropositive rate and seroconversion rate were 100%,the GMC was 9.68 IU/mL,and the geometric mean increase(GMI)was 23.99.The incidence of adverse events 0~7 d after the first,second and third doses of rabies vaccine were 22.50%,13.45% and 4.24%,respectively.The local adverse events were mainly pain,and the systemic adverse events were mainly fever,fatigue/weakness,dizziness,joint pain,and diarrhea.Conclusion Approved rabies vaccine showed good safety and immunogenicity in pre-exposure prophylaxis of people≥18 years old.

关 键 词：冻干人用狂犬病疫苗(Vero细胞) 暴露前免疫 安全性 免疫原性 

分 类 号：R186.3[医药卫生—流行病学]