健康成年人接种两剂新型冠状病毒灭活疫苗后序贯加强免疫重组新型冠状病毒疫苗(CHO细胞)的免疫原性和安全性研究  

Immunogenicity and safety of recombinant novel coronavirus vaccine(CHO cell)after two doses of inactivated SARS-CoV-2 vaccine in healthy adults

作　　者：张尚孝 杨世龙 黄涛[1] 钟再新 赵俊仕[1] 李谞[1] 戴德芳[1] 胡春生[1] 孙九峰[3] 高立冬[1] ZHANG Shang-xiao;YANG Shi-long;HUANG Tao;ZHONG Zai-xin;ZHAO Jun-shi;LI Xu;DAI De-fang;HU Chun-sheng;SUN Jiu-feng;GAO Li-dong(Hunan Provincial Center for Disease Control and Prevention/Hunan Workstation for Emerging Infectious Disease Control and Prevention,Chinese Academy of Medical Sciences,Changsha,Hunan 410005,China;Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd,Hefei,Anhui 230088,China;Guangdong Provincial Institute of Public Health,Guangdong Provincial Center for Disease Control and Prevention,Guangzhou,Guangdong 511430,China)

机构地区：[1]湖南省疾病预防控制中心/中国医学科学院湖南新发突发传染病防治工作站,湖南长沙410005 [2]安徽智飞龙科马生物制药有限公司,安徽合肥230088 [3]广东省疾病预防控制中心广东省公共卫生研究院,广东广州511430

出　　处：《实用预防医学》2022年第4期385-390,共6页Practical Preventive Medicine

基　　金：湖南省自然科学基金项目(2021JJ70011);湖南省重点领域研发计划社会发展领域重点研发项目(2020SK3012湖南省新型冠状病毒感染的肺炎疫情监测系统研究);中国医学科学院中央级公益性科研院所基本科研业务费项目(2020HY320003湖南省新冠病毒病原学及传播特性研究)。

摘　　要：目的评价在接种两剂已上市新冠病毒灭活疫苗的人群中序贯加强免疫重组新型冠状病毒疫苗(CHO细胞)后的免疫原性和安全性,为制定新型冠状病毒疫苗的加强免疫策略提供科学依据。方法采用开放性试验设计,筛选入组360例已接种两剂新冠病毒灭活疫苗3~4个月、6~8个月、11~13个月的18周岁及以上研究对象并接种1剂重组新型冠状病毒疫苗(CHO细胞)。采集所有研究对象研究用疫苗接种前、接种后14 d血样,用于体液免疫检测,收集研究用疫苗接种后1个月内的所有不良事件。结果本研究入组360例研究对象,按研究对象加强免疫与基础免疫间隔时间分3组(A组91~120 d,B组181~240 d,C组331~390 d),各组120例,无研究对象脱落。三组年龄均值分别为38.13、40.22和45.73岁,各组间年龄差异有统计学意义(F=13.516,P<0.001),A、B组差异无统计学意义(P=0.168),C组和A、B组间差异均有统计学意义(P<0.001)。三组IgG GMC(几何平均浓度)免疫前分别为4.81、4.23、2.12 AU/ml,差异有统计学意义(F=10.054,P<0.001),C组和A、B组间差异均有统计学意义(P<0.001),A、B组间差异无统计学意义(P=0.520);三组免疫后IgG GMC分别为106.69、124.05、80.04 AU/ml,差异无统计学意义(F=2.028,P=0.133)。三组IgG抗体阳转率分别为84.17%、87.50%、79.17%,差异无统计学意义(χ^(2)=3.081,P=0.214)。免疫前血清针对Delta变异株和原型株不同组别的中和抗体滴度比较,三组原型株中和抗体GMT(几何平均滴度)为1∶2.18、1∶2.18、1∶2.19,差异无统计学意义(F=0.011,P=0.990);三组Delta变异株中和抗体GMT为1∶2.09、1∶2.17、1∶2.16,差异无统计学意义(F=0.378,P=0.686)。免疫后血清三组原型株中和抗体GMT为1∶31.09、1∶34.90、1∶21.98,差异无统计学意义(F=2.262,P=0.106);三组Delta变异株中和抗体GMT为1∶61.46、1∶77.44、1∶43.71,差异无统计学意义(F=2.105,P=0.123)。序贯加强免疫后血清对新型冠状病毒DObjective To evaluate the immunogenicity and safety of recombinant novel coronavirus vaccine(CHO cell)after sequential immunization in population inoculated with two doses of inactivated SARS-CoV-2 vaccine so as to provide a scientific basis for formulating the enhanced immunization strategy of the SARS-CoV-2 vaccine.Methods Open experimental design was used to screen 360 subjects aged 18 and above who had been inoculated with two doses of new coronavirus inactivated vaccine for 3-4 months,6-8 months,11-13 months and one dose of recombinant novel coronavirus vaccine(CHO cell).Blood samples of all subjects before and 14 days after vaccination were collected for humoral immunity test,and all adverse events within one month after vaccination were collected.Results In this study,360 subjects were divided into three groups according to the interval between fundamental immunity and booster(group A 91-120 days,group B 181-240 days,group C 331-390),120cases in each group,and no subject was dropped off.The mean age of the three groups was 38.13,40.22 and 45.73 years,respectively,and the age difference among the groups was statistically significant(F=13.516,P<0.001).There was no significant difference between groups A and B(P=0.168),but the difference between groups C and A,B was statistically significant(both P<0.001).The IgG geometric mean concentration(GMC)of the three groups before booster immunization was 4.81 AU/ml,4.23 AU/ml and 2.12 AU/ml,respectively,showing statistically significant differences(F=10.054,P<0.001).The differences between groups C and A,B were statistically significant(bothP<0.001),but no statistically significant difference was found between groups A and B(P=0.520).The IgG GMC of the three groups after booster were 106.69 AU/ml,124.05 AU/ml and80.04 AU/ml,respectively,with no statistically significant difference(F=2.028,P=0.133).The positive conversion rates of IgG antibody in the three groups were 84.17%,87.50%and 79.17%,respectively,and the difference was not statistically significant(χ^(2)=3.08

关 键 词：新型冠状病毒疫苗 加强免疫 免疫原性 成年人 

分 类 号：R186[医药卫生—流行病学]