某公司国产流行性感冒裂解疫苗安全性和免疫原性研究  

STUDY ON SAFETY AND IMMUNOGENICITY OF NATIONAL SPLIT INFLUENZA VIRUS VACCINE

作　　者：华伟玉[1] 蒲永兰[1] 沈艳辉[1] 赵振[1] 

机构地区：[1]北京市海淀区疾病预防控制中心,北京100037

出　　处：《现代预防医学》2009年第4期756-759,共4页Modern Preventive Medicine

摘　　要：[目的]评价某国产流行性感冒裂解疫苗在儿童和成人中应用的安全性及免疫原性,为推广国产流感疫苗的预防接种提供科学依据。[方法]选择6月龄以上健康人群120人作为受试人群,分成6个年龄组,于上臂三角肌肌内接种某公司流行性感冒裂解疫苗,考核和评价疫苗的安全性和免疫原性。[结果]实验疫苗接种首针后全身及局部反应发生率分别为5%及4.17%,该疫苗在18～60岁人群中和≥60岁人群中分型抗体阳转率均≥50%,18～60岁人群和≥60岁人群分型抗体GMT增长﹥4.0倍,18～60岁和≥60岁易感者保护率均≥90%。[结论]本次研究结果与诸多同类疫苗临床反应率大致相同,提示该疫苗具有较好的临床安全性。免疫效果达到欧盟流感疫苗临床试验评价标准。[Objective] To evaluate safety and immunogenicity of national split influenza virus vaccine applied to children and adults, so as to provide scientific basis for popularizing vaccination of national influenza virus Vaccine. [Methods] 120 healthy people aged over than six months were selected and divided into six groups to inject national split influenza virus vaccine in the triangular muscle of upper arm, and the safety and immunogenicity were checked and evaluated. [Results] The incidence rates of systemic and partial clinic reaction were 5% and 4.17%, respectively. The positive conversion rate of typing antibody in people at the age of 18 to 60 years and above 60 years Who accepted national split influenza virus vaccine was above 50%. In people at the age of 18 to 60 years and above 60 years, the GMT increased by four times, and the protective rate of susceptible people was above 90%： [Conclusion] Compared to congeneric vaccines, it is approximately the same in the rate of clinic reaction, which indicates that this vaccine had effective clinical safety. The effect of immunogenieity has reached the criterion of clinic experimentation in European federation.

关 键 词：流感 流感病毒 安全性 免疫原性 抗体阳转率 抗体几何平均滴度(GMT) 疫苗保护率 

分 类 号：R186[医药卫生—流行病学]