A+C群脑膜炎球菌多糖结合疫苗对婴幼儿人群的免疫原性研究  

Immunogenicity of group A+C meningococcal polysaccharide conjugate vaccine in infants:A phaseⅢclinical trial study

作　　者：黄丽莉[1] 马晓敏 黄海涛 谢志强[1] 苟锦博 杨永利[3] 王雪 张伟[1] 由汪洋 谭洁冰 许丽锋 冯光伟 朱涛 王彦霞[1] Huang Lili;Ma Xiaomin;Huang Haitao;Xie Zhiqiang;Gou Jinbo;Yang Yongli;Wang Xue;Zhang Wei;You Wangyang;Tan Jiebing;Xu Lifeng;Feng Guangwei;Zhu Tao;Wang Yanxia(Center of Vaccine Clinical Trial,Henan Center for Disease Control and Prevention,Zhengzhou 450016,China;CanSino Biologics Inc.,Tianjin 300457,China;Department of Epidemiology and Biostatistics,College of Public Health,Zhengzhou University,Zhengzhou 450001,China)

机构地区：[1]河南省疾病预防控制中心疫苗临床研究中心,郑州450016 [2]康希诺生物股份公司临床运营中心,天津300457 [3]郑州大学公共卫生学院计算机与卫生统计学教研室,郑州450001

出　　处：《中华预防医学杂志》2022年第12期1728-1733,共6页Chinese Journal of Preventive Medicine

基　　金：疫苗临床评价技术平台建设(2018ZX09734004)。

摘　　要：目的评价国产A+C群脑膜炎球菌多糖结合疫苗对2岁以下婴幼儿的免疫原性。方法将2017年3月至2018年6月河南省泌阳县1932名2岁以内未接种过流脑疫苗且腋下体温≤37.0℃健康婴幼儿纳为对象。将3月龄组和6~11月龄组对象按1∶1比例分配至试验组和对照组,将12~23月龄组对象按1∶1∶1比例分配至1剂次组、2剂次组和对照组,每组含276名对象。试验组对象肌内注射待评价冻干剂型A+C群脑膜炎球菌结合疫苗,对照组对象肌内注射市售冻干剂型A+C群脑膜炎球菌结合疫苗。接种前和最后一剂次接种30 d后采集对象静脉血,测定并比较各组抗体阳转情况。结果免疫原性研究完成率为95.2%(1839/1932)。接种前,3月龄和6~11月龄对象试验组和对照组A群和C群抗体GMT和阳性率差异均无统计学意义(均P>0.05);12~23月龄对象1剂次组A群抗体GMT和阳性率高于对照组(均P<0.05),2剂次组与对照组差异无统计学意义(均P>0.05)。接种后,试验组和对照组A、C群抗体阳转率率差(95%CI)在3月龄对象分别为-0.12%(-6.01%~5.77%)和0.82%(-4.23%~5.86%);在6~11月龄对象分别为6.75%(1.71%~11.79%)和-4.32%(-8.73%~0.08%);在12~23月龄对象分别为1.02%(-3.80%~5.83%)和-4.40%(-7.79%~-1.01%)(2剂次组),-7.22(-12.90~-1.54)和-18.61(-23.75~-13.46)(1剂次组);A群和C群抗体几何平均滴度在3月龄对象试验组分别为48.50和63.12,与对照组差异无统计学意义(分别为43.02和57.99)(均P<0.05),在6~11月龄和12~23月龄对象分别为84.09和92.51(2剂次组),均高于各自对照组(分别为43.10和61.83)(均P<0.001)。结论A+C群脑膜炎球菌结合疫苗在2岁以下婴幼儿中具有较好的免疫原性。Objective To evaluate the immunogenicity of group A+C meningococcal polysaccharide conjugate vaccine in infants under 2 years old.Methods From March 2017 to June 2018,1932 healthy infants in Biyang County,Henan Province,who were not vaccinated with meningococcal meningitis vaccine and whose axillary temperature was≤37.0℃,were recruited as participants.The 3 months and 6-11 months old infants were allocated to the experiment group and the control group in a ratio of 1∶1.Infants aged 12-23 months were allocated to the 1-dose group,the 2-dose group and the control group in a ratio of 1∶1∶1,with 276 infants in each group.The infants in the experiment group were intramuscularly injected with freeze-dried group A+C meningococcal polysaccharide conjugate vaccine to be evaluated,and infants in the control group received intramuscular injection of commercially available freeze-dried group A+C meningococcal conjugate vaccine.The venous blood of infants was collected 30 days before the first dose and after the last dose of inoculation,and the antibody seroconversion of each group was determined and compared.Results The completion rate of immunogenicity study was 95.2%(1839/1932).Before inoculation,there was no statistical difference in the geometric mean titer and positive rate of group A+C antibodies between the experiment group and the control group in 3 months and 6-11 months old infants(all P values>0.05).The geometric mean titers and positive rate of group A antibodies in the 1-dose group were higher than those in the control group(all P values<0.05),but there was no statistical difference between the 2-dose group and the control group(all P values>0.05)in infants aged 12-23 months.After inoculation,the differences(95%CI)in the positive conversion rate of group A+C antibodies between the experiment group and the control group were-0.12%(-6.01%-5.77%)and 0.82%(-4.23%-5.86%)in the 3 months old infants.At the age of 6-11 months,the differences were 6.75%(1.71%-11.79%)and-4.32%(-8.73%-0.08%),respectively.At the a

关 键 词：A群C群脑膜炎球菌多糖结合疫苗 免疫原性 对比研究 

分 类 号：R186[医药卫生—流行病学]