摘要
目的:评价新型冠状病毒(SARS-CoV-2)灭活疫苗在18~59岁人群中按两针程序接种后的免疫持久性。方法:筛选280例合格的18~59岁受试者,按照两剂研究疫苗的免疫程序时间分为第0、14天,第0、21天和第0、28天3个程序组,人数分别为112例、56例和112例,将各组受试者按照3∶1的比例随机分配到试验组或安慰剂组,分别接种试验疫苗(北京生物制品研究所有限责任公司研制)或安慰剂。计算全程免疫后第28、90和180天时抗体的几何平均滴度(GMT)和抗体4倍增长率,评价免疫持久性。结果:第0、14天程序试验组中和抗体和IgG抗体GMT在全程免疫后第90天(178.4和152.2)时高于第180天(58.7和69.9);第0、21天程序试验组中和抗体GMT在全程免疫后第90天(273.9)时高于第180天(74.8);第0、28天程序试验组中和抗体和IgG抗体GMT在全程免疫后第90天(272.4和239.7)时高于第180天(75.2和125.9)。3个程序试验组全程免疫后第90和180天时,中和抗体4倍增长率均为100%,IgG抗体4倍增长率均超过90%。结论:SARS-CoV-2灭活疫苗在18~59岁人群中按照两针的免疫程序接种后,在全程免疫后第90天时维持较高的免疫应答水平,在第180天时免疫水平呈明显下降。
Aim:To evaluate the immune persistence of an inactivated SARS-CoV-2 vaccine in participants aged 18-59 years after two injections.Methods:A total of 280 eligible subjects aged 18-59 years were screened and allocated into 3 schedule groups(days 0 and 14th,days 0 and 21th,and days 0 and 28th),and the sample sizes were 112,56 and 112,respectively.Subjects in each group were randomly assigned to the vaccine group or the placebo group according to the ratio of 3∶1,and were inoculated with the vaccine(developed by Beijing Institute of Biological Products Co.,Ltd.)or placebo.The geometric mean titer(GMT)and 4-fold increase rate of antibody at the 28th,90th and 180th days after the full vaccination course were calculated to evaluate the immune persistence.Results:In the days 0 and 14th schedule group,the GMT of neutralizing antibody and IgG antibody of the vaccine group were higher on the 90th day(178.4 and 152.2)than the 180th day(58.7 and 69.9)after the full vaccination course.In the days 0 and 21th schedule group,the GMT of neutralizing antibody of the vaccine group was higher on the 90th day(273.9)than the 180th day(74.8).In the days 0 and 28th schedule group,the GMT of neutralizing antibody and IgG antibody of the vaccine group were higher on the 90th(272.4 and 239.7)than the 180th day(75.2 and 125.9).The 4-fold increase rate of neutralizing antibody was 100%and the 4-fold increase rate of IgG antibody was more than 90%on the 90th and 180th days after the full vaccination course in 3 schedule groups.Conclusion:The immune response remained at a high level on the 90th day and decreased significantly on the 180th day in the subjects aged 18-59 years receiving two doses of inactivated SARS-CoV-2 vaccine.
作者
谭洁冰
王伟
王慧娟
张伟
杨云凯
谢志强
杨旭琴
黄丽莉
冯光伟
王辉
卢洁
施学忠
张云涛
王彦霞
黄保英
TAN Jiebing;WANG Wei;WANG Huijuan;ZHANG Wei;YANG Yunkai;XIE Zhiqiang;YANG Xuqin;HUANG Lili;FENG Guangwei;WANG Hui;LU Jie;SHI Xuezhong;ZHANG Yuntao;WANG Yanxia;HUANG Baoying(Vaccine Clinical Trial Center,Henan Center for Disease Control and Prevention,Zhengzhou 450016;Scientific Research Management Department,Beijing Institute of Biological Products Co.,Ltd.,Beijing 100176;Central Laboratory,National Institute for Viral Disease Control and Prevention,China Center for Disease Control and Prevention,Beijing 102206;Scientific Research Management Department,China National Biotec Group Company Limited,Beijing 100024;Department of Computer and Health Statistics,College of Public Health,Zhengzhou University,Zhengzhou 450001)
出处
《郑州大学学报（医学版）》
CAS
北大核心
2022年第5期635-639,共5页
Journal of Zhengzhou University(Medical Sciences)
基金
河南省医学科技攻关计划联合共建项目(LHGJ20210133)
“重大新药创制”科技重大专项(2018ZX09734004)。
关键词
新型冠状病毒灭活疫苗
两针程序
免疫持久性
inactivated vaccine against SARS-CoV-2
two doses of vaccine
immune persistence
