首页|免疫球蛋白制剂对SARS-CoV-2体外中和活性的分析

免疫球蛋白制剂对SARS-CoV-2体外中和活性的分析

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目的 评价疫苗接种前后人群对SARS-CoV-2及其变异株的中和抗体水平.方法 收集37份免疫球蛋白制剂样本,根据采浆时间,以我国SARS-CoV-2疫苗加强针接种时间(2021年9月)和防疫政策变更时间(2022年12月)作为节点,将不同时间段内生产的免疫球蛋白制剂分为3组:1组共19份,采浆时间为2019年2月—2021年10月;2组共8份,采浆时间为2022年3月—2022年12月7日;3组共10份,采浆时间为2023年1-2月.采用微量中和抗体试验检测野生株、德尔塔变异株、奥密克戎变异株BA.5、BQ.1和XBB中和抗体水平,并计算抗体几何平均滴度(geo-metric mean titer,GMT).结果 2021年前采浆制备的19份免疫球蛋白制剂中,仅5份检测到SARS-CoV-2野生株中和抗体,滴度均不超过1∶20,未检出其他4种变异株中和抗体.2022年3-12月采浆制备的8份免疫球蛋白制剂中,对于5种SARS-CoV-2毒株的中和抗体滴度均明显增加,其中野生株(1∶2 560)和德尔塔变异株(1∶1 810)最高,奥密克戎变异株次之(GMTBA5=1∶830;GMTXBB=1∶104;GMTBQ.1=1∶22);2023年采浆制备的10份免疫球蛋白制剂中,5种毒株中和抗体滴度变化不大,野生株为1∶2 079,德尔塔变异株为1∶1 114,奥密克戎变异株BA.5、BQ.1、XBB分别为1∶970、1∶69、1∶121;5种毒株GMT在该2组免疫球蛋白制剂中的差异均无统计学意义(t分别为1.249、1.495、0.3702、1.160、0.502 8,P 均>0.05).结论 我国实施 SARS-CoV-2 疫苗加强针接种后,SARS-CoV-2中和抗体水平在免疫球蛋白制剂中显著上升,但相对于奥密克戎及其分支株毒株,SARS-CoV-2灭活疫苗对SARS-CoV-2野生株和德尔塔株的保护效果更佳.
Neutralizing activity of immunoglobulin preparations against SARS-CoV-2 in vitro
Objective To evaluate the neutralizing antibody level of the population to SARS-CoV-2 and its variants before and after vaccination.Methods A total of 37 samples of immunoglobulin preparations were collected.According to the time of plasma collection,taking the time of SARS-CoV-2 vaccine intensive inoculation(September 2021)and the time of epidemic prevention policy change(December 2022)as nodes,the immunoglobulin preparations produced in different time periods were divided into three groups:19 samples of plasma collected from February 2019 to October 2021 in group 1,8 samples of plasma collected from March 2022 to December 7,2022 in group 2,and 10 samples of plasma collected from January 2023 to February 2023 in group 3.The neutralizing antibody levels of the wild strain,Delta strain,Omicron BA.5,BQ.1 and XBB variant strains were measured by micro neutralizing antibody assay,and the geometric mean titers(GMTs)of the antibodies were calculated.Results The SARS-CoV-2 wild strain neutralizing antibody was detected in only 5 of the 19 immunoglobulin preparations prepared by plasma collected before 2021,with the titer of not more than 1∶20,and no neutralizing antibody against the other four variants was detected.From March to December 2022,the neutralizing antibody titers of eight immunoglobulin preparations against the five SARS-CoV-2 strains increased significantly,of which the wild strain(1∶2 560)and Delta strain(1∶1 810)had the highest titers,followed by the Omicron strains(GMTBA.5=1∶830;GMTXBB=1∶104;GMTBQ.1=1∶22).Among the 10 immunoglobulin preparations prepared by plasma collected in 2023,the neutralizing antibody titers of the five strains showed little change.The GMTs of the five strains of antibodies were:wild strain(1∶2 079),Delta strain(1∶1 114),Omicron BA.5(1∶970),Omicron BQ.1(1∶69),and Omicron XBB(1∶121).There was no significant difference in the GMTs of the five strains between the two groups of immunoglobulin preparations(t=1.249,1.495,0.370 2,1.160 and 0.502 8,respectively,each P>0.05).Conclusion The neutralizing antibody level of SARS-CoV-2 has significantly increased in immunoglobulin products after the implementation of enhanced inoculation of SARS-CoV-2 vaccine in China,while compared with Omicron and its branch strains,inactivated SARS-CoV-2 vaccine has better protection effect on SARS-CoV-2 wild strain and Delta strain.

Immunoglobulin preparationsSARS-CoV-2Inactivated vaccineNeutralization testNeutralizing antibody

邹敏、肖允、江捷莹、陈乐妍、陈启方、马小伟、张学成、李冠军、柯昌文、彭晓放

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中山大学公共卫生学院,广东 广州 510080

广东省疾病预防控制中心广东省新发传染病应急检测技术研究与应用重点实验室,广东 广州 510080

南方医科大学公共卫生学院,广东 广州 510080

汕头大学公共卫生学院,广东汕头 515000

广州中医药大学中药学院,广东 广州 510080

华兰生物工程股份有限公司,河南新乡 453000

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免疫球蛋白制剂 新型冠状病毒 灭活疫苗 中和试验 中和抗体

2024

中国生物制品学杂志
中华预防医学会,长春生物制品研究所有限责任公司

中国生物制品学杂志

CSTPCD
影响因子:0.417
ISSN:1004-5503
年,卷(期):2024.37(12)