国产b型流感嗜血杆菌结合疫苗的免疫原性  

Immunogenicity of primary immunization with Hib PRP-TT conjugates vaccine

作　　者：张丽莺 储凯[2] 朱加宏[3] 朱凤才[2] ZHANG Li-ying;CHU Kai;ZHU Jia-hong;ZHU Feng-cai(Department of Registratipn ,Chengdu Olymvax Biopharmaceutical Inc ,Chengdu Sichuan 610000,China)

机构地区：[1]成都欧林生物科技股份有限公司注册部,四川成都610000 [2]江苏省疾病预防控制中心 [3]江苏省涟水县疾病预防控制中心

出　　处：《中国卫生工程学》2018年第6期841-843,共3页Chinese Journal of Public Health Engineering

摘　　要：目的评价国产b型流感嗜血杆菌结合疫苗在3月龄~5岁婴幼儿中的免疫原性。方法将江苏省涟水县3月龄~5岁适宜接种b型流感嗜血杆菌结合疫苗的健康婴幼儿作为观察对象。按0、1、2月的免疫程序,3~5月龄儿接种3剂Hib结合疫苗,并于第3剂接种后1年加强免疫1剂;按0、1月(28 d)的免疫程序,6~11月龄儿接种2剂;1~5岁婴幼儿接种1剂。3~11月龄儿接种部位为臀部外上方1/4处肌内、1~5岁婴幼儿接种部位为上臂三角肌外侧肌内。分别于受种儿免疫前、3~5月龄儿第3针接种后1月(28 d)及加强免疫后1月(28 d)、6~11月龄儿第2针免疫后1月(28 d)、1~5岁婴幼儿第1针免疫后1月(28 d),采集每个受种儿静脉血,分离血清,ELISA法检测每份血清抗Hib PRP抗体,并计算血清抗Hib PRP抗体的几何平均浓度(GMC)和几何平均浓度增长倍数(GMFI)。结果免疫接种后,各年龄组受种儿血清抗Hib PRP抗体浓度均≥1.0μg/ml,均获得了长期保护水平;1~5岁、6~11月龄、3~5月龄受种儿免疫后Hib抗体GMC分别达到131.22、14.86、15.59μg/ml,GMFI达到42.13、47.61、121.59,均较免疫前大幅升高。3~5月龄儿加强免疫1剂后,血清Hib抗体GMC由15. 19μg/ml升至57.21μg/ml。结论国产b型流感嗜血杆菌结合疫苗免疫3月龄~5岁婴幼儿后,均获得了较好的免疫原性。Objective To evaluate the immunogenicity of haemophilus influenza type b conjugate vaccine used in the children 3 months through 5 years of age. Methods The healthy children 3 months through 5 years of age from Jiangsu province were observed in this research. Infants of 3 to 5 months-old received 3 doses of Hib-TT,infants of 6 to 11 months-old received 2 doses,and 1 to 5 year-old children received one dose of Hib-TT,each at an interval of one month and vastus lateralis muscle injection.Hib-PRP antibody levels in sera were determined before the first dose,28 d after the last dose and 28 d after the booster by ELISA respectively,and calculate the sera antibody GMC and GMFI.Results After the whole primary immunization series,100% of children 3 months through 5 years of age would achieve antibody concentrations of 1.0 μg/ml,the long-term protection. The antibody GMC in three groups of children 3 months through 5 years of age were respectively 131.22 μg/ml,14.86 μg/ml,15.59 μg/ml,and the GMFI were respectively 42.13,47.61,121.59.After boost dose,the antibody GMC of children 3-5 months of age was 57.21μg/ml,and 100% of children in this group achieved the antibody of long-term protection.Conclusion The Haemophilus influenza type b conjugate vaccine is proved to be efficacious in children 3 months through 5 years of age.

关 键 词：B型流感嗜血杆菌结合疫苗 免疫原性 几何平均浓度 几何平均浓度增长倍数 

分 类 号：R511.7[医药卫生—内科学] R378.4[医药卫生—临床医学]