A＋C群脑膜炎球菌多糖疫苗安全性和免疫原性的研究  

Study on the safety and immunogenicity of group A ＋ C meningococcal polysaccharide vaccine

作　　者：何莉[1] 李荣成[2] 李亚南[1] 黄运能 姚群 袁曾麟[1] 李凤祥[1] 崔萱林[5] 农艺[2] 杨明[5] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]广西壮族自治区疾病预防控制中心 [3]桂林市疾病预防控制中心 [4]龙胜各族自治县疾病预防控制中心 [5]兰州生物制品研究所

出　　处：《中华流行病学杂志》2007年第5期422-425,共4页Chinese Journal of Epidemiology

摘　　要：目的 以分组对照法观察A＋C群脑膜炎球菌多糖疫苗对6～24月龄幼儿和5～13岁儿童接种后的安全性和免疫原性。方法 观察组共428名儿童,分为2个年龄段接种A＋C群脑膜炎球菌多糖疫苗,接种剂量为每人100μg;阳性对照组103人接种A群脑膜炎球菌多糖疫苗,接种剂量为每人50μg;阴性对照组94人接种伤寒Vi多糖疫苗,接种剂最为每人30μg;各组于接种后6、24、48和72 h测量体温并观察全身和局部反应,并于免疫前、后1个月分别收集血清标本,观察组2个年龄段儿童各不少于50名于免疫后6个月和1年再次收集血清标本,免疫前后收集到的血清采用体外杀菌力试验方法进行杀菌抗体水平的测定。结果 疫苗接种后人体反应轻微,428名儿童仅有3名（0．7%）出现中、强发热反应,有4名（0．9%）出现局部红晕,48h后反应全部消失。5～13岁儿童组免疫后1个月抗A和C群脑膜炎球菌杀菌抗体4倍增长率分别为96．59%和92．15%,免后1年的4倍增长率仍保持在90．91%和90．08%。结论A＋C群脑膜炎球菌多糖疫苗接种后具有较好的安全性和免疫原性。Objective In order to evaluate the safety and immunogenicity of group A＋ C meningococcal polysaccharide vaccine,a controlled field trial was performed among children at 6-24 months and 5-13 years old in Longsheng county,Guangxl Zhuang Autonomous Region. Methods More than 600 children were selected in this trial. 428 children, aged 6-24 month-old and 5-13 year-old were involved in two experimental groups and were inoculated 100 #g of group A ＋ C meningococcal polysaccharide vaccine. 103 children in positive control group were inoculated 50 μg of group A meningococcal polysaccharide vaccine while 94 children in negative control group were inoculated 30 μg of Typhoid Vi polysaccharide vaccine. Both systemic and local reactions were observed in each group at 6 h,24 h, 48 h and 72 h after inoculatiorL Blood samples were collected in all children before and at 1 month after inoculation. Additionally, at least 50 blood samples were taken in each experimental group at 6 and 12 months after inoculation. Serum bactericidal antibody was tested by micro bactericidal test. Results Both systemic and local reactions were mild in two experimental groups with only 3 children（0.7 % ） had≥37.6℃ fever, 4 children（0.9% ） appeared mild areola but all adverse reaction disappeared within 48 hours. In 5-13 year-old experimental group,the rates for four-fold increase of bactericidal antibody were 96.59 % and 92.15 % to group A and group C meningococcus respectively at 1 month after inoculation,and remained 90.91% and 90.08% at 12 months after inoculation. Conclusion Group A ＋ C meningococal polysaccharide vaccine was safe and having good immunogenicity among Chinese children.

关 键 词：疫苗 A+C群脑膜炎球菌多糖 安全性 免疫原性 杀菌抗体 

分 类 号：R686[医药卫生—骨科学]