献浆人群接种第3剂次新型冠状病毒灭活疫苗后中和抗体水平变化研究  

Study on the change of neutralizing antibody level in plasma donors after a third shot of inactivated novel coronavirus vaccine

作　　者：葛文娟 周安 沈俊莹 李晓轻 马杰 朱孟沼 菅长永 GE Wenjuan;ZHOU An;SHEN Junying;LI Xiaoqing;MA Jie;ZHU Mengzhao;JIAN Changyong(Shandong Taibang Biological Products Co.,Ltd,Tai’an 271000,China)

机构地区：[1]山东泰邦生物制品有限公司,山东泰安271000

出　　处：《中国输血杂志》2023年第5期410-415,共6页Chinese Journal of Blood Transfusion

摘　　要：目的了解普通献浆人群接种第3剂次新型冠状病毒灭活疫苗后中和抗体水平变化情况。方法2021年12月—2022年6月,以假病毒中和试验为标准,对市售的3家新型冠状病毒中和抗体ELISA试剂盒(厂家A、B、C)进行筛选;2022年7月—2022年10月,使用筛选出的ELISA试剂盒对64名献浆员接种第3剂次新型冠状病毒灭活疫苗6个月内血浆(410份)进行检测,应用Excel2013、SPSS 26软件进行数据分析。结果厂家A为合适的高通量抗-SARS-CoV-2中和抗体ELISA试剂盒。接种第3剂次疫苗后1~6个月混合血浆效价分别为1337.34 U/mL、1148.89 U/mL、852.19 U/mL、681.38 U/mL、556.44 U/mL、457.19 U/mL;接种后7d左右中和抗体水平开始升高,约1个月(范围:9~43日,中位数:22日)可达到峰值[峰值范围:(264.07~2208.39)U/mL,中位数:569.34 U/mL],随后效价呈逐渐下降趋势(P<0.05)。结论献浆人群接种第3剂次新型冠状病毒灭活疫苗后7日左右中和抗体效价开始升高,1个月左右可达到峰值,之后逐渐下降。Objective To investigate the trend of neutralizing antibody level in plasma donors who received the 3rd shot of inactivated novel coronavirus vaccine.Methods Three commercial ELISA kits for novel coronavirus neutralization antibody detection,manufactured by Company A,B and C,were chosen and screened by Pseudotype Neutralization Test from December 2021 to June 2022.A total of 410 plasma samples from 64 plasma donors who received the 3rd shot of inactivated novel coronavirus vaccine and there after donated plasma within six months were detected by the selected ELISA kit from July to October,2022.The data were analyzed by Excel 2013 and SPSS 26 software.Results The high-throughput ELISA kit for SARS-CoV-2 neutralizing antibody detection,manufactured by Company A,was selected for further antibody titer detection.The mixed plasma titers were 1337.34,1148.89,852.19,681.38,556.44 and 457.19 U/mL from 1 to 6 months,respectively,after the 3rd shot of vaccine.The neutralizing antibody titer level began to increase around 7 days after the 3rd shot of vaccine injection and peaked(peak range:264.07-2208.39 U/mL,median:569.34 U/mL)at 1 month(range:9-43 days,median:22 days),and then gradually decreased(P<0.05).Conclusion The neutralizing antibody titer of plasma donors who received the 3rd shot of inactivated novel coronavirus vaccine began to rise around 7 days after vaccination,which reached the peak value at around 1 month and then gradually decreased.

关 键 词：新型冠状病毒灭活疫苗 ELISA试剂盒筛选 中和抗体水平变化 

分 类 号：R457.11[医药卫生—治疗学] R193.3[医药卫生—临床医学]