国产流行性感冒病毒裂解疫苗临床安全性和免疫原性观察  

Observation on Safety and Immunogenicity of Domestic Split Influenza Virus Vaccine

作　　者：陈昌标[1] 郑春早 顾建祥[1] 王树巧[3] 柴文清[3] 

机构地区：[1]江苏省射阳县疾病预防控制中心,江苏射阳224300 [2]盐城市疾病预防控制中心 [3]上海生物制品研究所

出　　处：《实用预防医学》2009年第2期397-399,共3页Practical Preventive Medicine

摘　　要：目的评价2007年变更后流感毒株生产的流行性感冒病毒裂解疫苗安全性和免疫原性。方法在江苏省射阳县选择500名观察对象,按随机的原则开展现场临床试验。结果上海生物制品研究所2007年变更后流感毒株生产的流行性感冒病毒裂解疫苗全身及局部反应发生率分别为1.5%、4.67%。血清学检测表明,免疫后H1N1型、H3N2型、B型HI抗体阳性率(抗体滴度≥1:40)分别为99.13%、99.13%和100%。免后HI抗体4倍增长率,除13～17岁组H3N2型为52.83%外,其他各组中各型别HI抗体均达到78%以上。各型各组免后HI抗体GMT增长倍数较免前均>3.9倍。结论流行性感冒病毒裂解疫苗是安全有效的。Objective To evaluate the safety and immunogenicity of domestic split influenza virus vaccine which advanced in 2007 by Shanghai Institute of Biological Products. Methods A random study was carried out in Sheyang County, Jiangsu Province and 500 subjects were selected. Results After immunization, the systemic and local reaction rates of domestic split influenza vaccine were 1.5 % and 4.67 %, respectively. The seroconversion rates of antibodies HI titers of H1N1, H3N2, and B were 99.13%, 99.13%, and 100%, respectively. Antibodies HI titers rose four-fold, which were morethan 78 % in all groups except the group aged between 13 and 17 years of H3 N2 （52.83 % ）. The HI geometric mean titers （GMT） were all increased 3.9 folds in all groups. Conclusions Clinical trial indicates that the safety of split influenza virus vaccine has reached a satisfactory level.

关 键 词：流行性感冒病毒裂解疫苗 安全性 免疫原性 

分 类 号：R186[医药卫生—流行病学]