接种新型冠状病毒灭活疫苗血清抗体水平分析  

Detection of serum antibody levels after inoculation of an inactivated SARS-CoV-2 vaccine

作　　者：徐娜妮[1] 胡小炜[1] 李海燕 郑琳[1] 孔庆鑫[3] 覃盼 李静[1] 叶非 XU Nani;HU Xiaowei;LI Haiyan;ZHENG Lin;KONG Qingxin;QIN Pan;LI Jing;YE Fei(Department of Immunization Program,Xihu District Center for Disease Control and Prevention,Hangzhou,Zhejiang 310030,China;Hangzhou Di'an Medical Laboratory Co.,Ltd,Hangzhou,Zhejiang 310012,China;Hangzhou Center for Disease Control and Prevention,Hangzhou,Zhejiang 310021,China;Hangzhou Xixi Hospital,Hangzhou,Zhejiang 310023,China)

机构地区：[1]杭州市西湖区疾病预防控制中心免疫规划科,浙江杭州310030 [2]杭州迪安医学检验中心有限公司,浙江杭州310012 [3]杭州市疾病预防控制中心,浙江杭州310021 [4]杭州市西溪医院,浙江杭州310023

出　　处：《预防医学》2022年第1期33-36,41,共5页CHINA PREVENTIVE MEDICINE JOURNAL

基　　金：2021年浙江省重点研发计划应急攻关项目(2021C03200);杭州市新型冠状病毒感染的肺炎防治科研攻关项目(第一批)(20202013A02);杭州市科技发展计划项目(20201203B27)。

摘　　要：目的了解接种新型冠状病毒(新冠病毒)灭活疫苗后血清抗体水平,为评价新冠病毒灭活疫苗免疫原性提供依据。方法采用单组目标值试验设计,整群抽取2020年10—12月在杭州市西湖区接种新冠病毒灭活疫苗的18~59岁居民为研究对象。采集接种前,接种1剂次后14 d、28 d和接种2剂次后28 d的血样,应用磁微粒化学发光法检测新冠病毒IgG和IgM抗体,分析抗体阳转率和抗体浓度变化情况。结果纳入研究对象310人,接种1剂次后14 d、28 d和接种2剂次后28 d分别调查133人、97人和254人,新冠病毒IgG抗体阳转率分别为6.02%、28.87%和98.43%,抗体浓度[M(Q_(R))]分别为1.76(3.25)、5.69(9.95)和52.05(47.60)AU/mL,抗体浓度差异有统计学意义(P<0.05);新冠病毒IgM抗体阳转率分别为9.02%、11.34%和12.99%,抗体浓度分别为1.89(3.28)、2.06(4.71)和2.65(4.01)AU/mL,抗体浓度差异无统计学意义(P>0.05)。接种后新冠病毒IgG和IgM抗体浓度均高于接种前(P<0.05)。18~<40岁组新冠病毒IgG抗体浓度高于40~59岁组(P<0.05)。结论18~59岁人群全程接种新冠病毒灭活疫苗后28 d呈现较好的免疫原性;部分受种者在接种1剂次后14 d、28 d可检出新冠病毒IgM抗体阳性。Objective To investigate the serum levels of antibodies against SARS-CoV-2 after inoculation of an inactivated SARS-CoV-2 vaccine,so as to provide insights into the evaluation of the vaccine immunogenicity.Methods In this single-arm objective performance criteria trial,residents aged 18 to 59 years and inoculated with an inactivated SARS-CoV-2 vaccine in Xihu District,Hangzhou City from October to December of 2020 were selected using a cluster sampling method.Blood samples were collected prior to inoculation,14 and 28 days post-inoculation of the first dose,and 28 days post-inoculation of the second dose.Serum levels of anti-SARS-CoV-2 IgM and IgG antibodies were detected using the magnetic particle-based chemiluminescence immunoassay.The seroconversion of antibodies and dynamic changes of antibody levels were analyzed.Results Totally 310 participants were enrolled,including 133 subjects on day 14 post-inoculation of the first dose,97 subjects on day 28 post-inoculation of the first dose and 254 subjects on day 28 post-inoculation of the second dose.The seroconversion rates of anti-SARS-CoV-2 IgG antibody were 6.02%,28.87% and 98.43%,and the median IgG antibody levels were 1.76(interquartile range,3.25),5.69(9.95)and 52.05(47.60)AU/mL(P<0.05),respectively,while the seroconversion rates of anti-SARS-CoV-2 IgM antibody were 9.02%,11.34% and 12.99%,and the median IgG antibody levels were 1.89(3.28),2.06(4.71)and 2.65(4.01)AU/mL(P>0.05),respectively.In addition,higher serum levels of anti-SARS-CoV-2 IgG and IgM antibodies were detected post-inoculation relative to pre-inoculation(P<0.05),and higher serum IgG antibody levels were found in subjects aged 18 to 39 years than in those aged 40 to 59 years(P<0.05).Conclusions Inoculation of two doses of the inactivated SARS-CoV-2 vaccine achieves a high immunogenicity among residents aged 18 to 59 years 28 days post-inoculation,and the anti-SARS-CoV-2 IgM antibody is detectable in some residents following inoculation of the first dose.

关 键 词：新型冠状病毒 灭活疫苗 抗体 阳转率 

分 类 号：R186[医药卫生—流行病学]