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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 the influenza virus split vaccine produced by the influenza strains after the change in 2007. Methods 500 observation subjects were selected in Sheyang County, Jiangsu Province. On-site clinical trials were conducted according to the principle of randomness. Results The systemic and local reactions of influenza virus lysis vaccine produced by Shanghai Institute of Biological Products after the change in 2007 were 1.5% and 4.67%, respectively. Serological tests showed that the positive rate of HIN1, H3N2, and HI antibody after immunization (antibody titer≥1: 40) were 99.13%, 99.13% and 100% respectively. After HI, the 4-fold increase rate of HI antibody except for 13- to 17-year-old group was 52.83%, and the HI antibody of all other groups reached more than 78%. The growth of GMT of HI antibody in each group was> 3.9 times higher than before. Conclusions Influenza virus lysis vaccine is safe and effective.