纯化Vero细胞狂犬病疫苗Zagreb和Essen方案接种后的免疫原性和免疫持久性  

Immunogenicity and immune persistence of purified Vero cell rabies vaccine with Zagreb and Essen regimens

作　　者：罗静霞[1] 吕新军[2] 张丽芳[1] 梁伟献[1] 曾雪梅[1] 卢海金 韦利玲 梁桂荣 雷庆莲[1] Luo Jingxia;Lyu Xinjun;Zhang Lifang;Liang Weixian;Zeng Xuemei;Lu Haijin;Wei Liling;Liang Guirong;Lei Qinglian(Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention,Nanning 530028,China;National Institute for Viral Disease Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 100052,China)

机构地区：[1]广西壮族自治区疾病预防控制中心,南宁530028 [2]中国疾病预防控制中心病毒病预防控制所,北京100052

出　　处：《中华实验和临床病毒学杂志》2021年第6期612-618,共7页Chinese Journal of Experimental and Clinical Virology

基　　金：广西卫生健康委员会自筹课题(Z2015454)。

摘　　要：目的评价纯化Vero细胞狂犬病疫苗(purified vero cell rabies vaccine,PVRV)Zagreb和Essen方案接种后的免疫原性和免疫持久性。方法前瞻性研究:在广西壮族自治区疾病预防控制中心(广西CDC)犬伤门诊招募初次狂犬病暴露的Ⅱ级以下暴露者,随机分成Zagreb(2-1-1)方案组和Essen(1-1-1-1-1)方案组,全程接种同厂家同批号的PVRV,免疫后第45天、1年、2年及3年时各采静脉血3 ml分离血清,用快速荧光灶抑制试验(rapid fluorescent focus inhibition test,RFFIT)检测狂犬病病毒中和抗体(rabies virus neutralizing antibody,RVNA),分析RVNA阳性率和几何平均滴度(geometric mean titer,GMT)随时间推移而衰减情况。回顾性研究:查阅广西CDC犬伤门诊的狂犬病疫苗接种知情同意书,筛选3年内首次注射PVRV(同厂家但批号不限)且未使用被动免疫制剂的暴露者,分免疫满1年组、2年组及3年组,各组内又分Zagreb和Essen方案组,采集静脉血3 ml分离血清,用RFFIT法检测RVNA。结果前瞻性研究:Zagreb和Essen方案组全程免疫后的第45天、1年、2年及3年其RVNA阳性率分别为100%、95%、85%、80%和98.25%、89.47%、89.47%、85.96%,同一时间点两方案组的RVNA阳性率差异均无统计学意义(P>0.05);RVNA GMT分别为11.32 IU/ml、1.69 IU/ml、1.30 IU/ml、1.30 IU/m和13.18 IU/ml、2.13 IU/ml、1.87 IU/ml和1.84 IU/ml,同一时间点两方案组的RVNA GMT差异无统计学意义(F=1.971,P=0.164);两方案组RVNA GMT随时间推移而衰减的趋势一致(时间*组别F=0.702,P=0.435)。回顾性研究:Zagreb和Essen方案组在满1年组、2年组及3年组的RVNA阳性率分别为100%、95%、91.43%和94.73%、86.21%、87.5%,同一时间点两方案组的RVNA阳性率差异均无统计学意义(P>0.05);RVNA GMT分别为2.65 IU/ml、2.03 IU/ml、1.57 IU/ml和3.2 IU/ml、2.58 IU/ml、2.45 IU/ml,同一时间点两方案组的RVNA GMT差异均无统计学意义(t=0.534,P>0.05;t=0.401,P>0.05;t=1.419,P>0.05)。结论PVRV采用Zagreb和Essen方案接Objective To evaluate the immunogenicity and immune persistence of purified Vero cells rabies vaccine(PVRV)with Zagreb and Essen regimen.Methods Prospective study:Patients with first Class II exposure to rabies were recruited from the Dog Injury Cinic of Guangxi Center for Disease Control and Prevention(Guangxi CDC)and randomly divided into the Zagreb(2-1-1)and Essen(1-1-1-1-1)regimen group.All patients were inoculated with the vaccines from the same manufacturer and batch,and 3 ml serum was collected at the 45th day and in 1-year,2-year and 3-year after immunization.Rapid fluorescent inhibition test(RFFIT)was used to detect rabies virus neutralizing antibody(RVNA).The attenuation of RVNA positive rate and geometric mean titer(GMT)with time was analyzed.Retrospective study:The informed consents for rabies vaccine in the Dog Injury Clinic of Guangxi CDC were checked out.The patients who were injected with PVRV(same manufacturer but unlimited batch)but without passive immune agents for the first time within 3 years were selected and divided into 1-year,2-year and 3-year group.Each group was further divided into Zagreb and Essen regimen group.The serum(3 ml)was collected at 1 year,2 years and 3 years after immunization and detected the RVNA by RFFIT.Results Prospective study:The RVNA positive rates on the 45th day and in 1-year,2-year and 3-year after immunizationin in the Zagreb and Essen regimen group were 100%,95%,85%,80%and 98.25%,89.47%,89.47%,85.96%,respectively.There was no statistically significant difference in the RVNA positive rates at the same time point between the two regimen groups(P>0.05).The RVNA GMT on the 45th day and in 1-year,2-year,and 3-year in the Zagreb and Essen regimen group were 11.32 IU/ml,1.69 IU/ml,1.30 IU/ml,1.30 IU/m and 13.18 IU/ml,2.13 IU/ml,1.87 IU/ml,1.84 IU/m,respectively.There was no significant difference in the RVNA GMT levels at the same time point between the two regimen groups(F=1.971,P=0.164).The RVNA GMT levels in the two regimen groups had the same trend of attenuation

关 键 词：纯化Vero细胞狂犬病疫苗 Zagreb方案 Essen方案 狂犬病病毒中和抗体 

分 类 号：R392[医药卫生—免疫学] R512.99[医药卫生—基础医学]