流行性感冒裂解疫苗临床免疫效果观察  

Investigation safety and immunogenicity of the split influenza virus vaccine in human

作　　者：包红[1] 余黎[1] 胡广宏[1] 安红[1] 陈汉泉[1] 周旭[1] 方捍华[2] 刘淑贞[2] 李长贵[2] 

机构地区：[1]兰州生物制品研究所,兰州730046 [2]中国药品生物制品检定所,北京100050

出　　处：《微生物学免疫学进展》2006年第4期54-57,共4页Progress In Microbiology and Immunology

摘　　要：兰州生物制品研究所研制的流行性感冒病毒裂解疫苗于2003年9月-12月在广西进行Ⅰ～Ⅲ临床试验，对疫苗的安全性和免疫原性进行考核评价。试验中随机选取852人（6月龄-67岁）接种试验疫苗，227人接种对照疫苗。6—36月龄的婴幼儿接种2针，每次0．25ml，间隔28天；成人接种0．5ml。所有接种对象均未见红肿和硬结等局部反应；发生低热反应（37.1℃-37．5℃）率为3．5％，均于48小时内恢复正常。疫苗接种后易感人群的HI抗体总阳转率为100％，非易感人群的HI抗体几何平均效价增长7．1—16．8倍，抗体4倍增长率为73．1％-91．7％。证实该疫苗具有良好的安全性和免疫原性。The clinical trials of the split influenza virus vaccine were undertaken in Guangxi province by Lanzhou Institute of Biological Products. In this study, 852 persons （age range from six months old to 67 years old） were assigned randomly to receive one dose of testing vaccine ;227 persons were assigned to receive one dose of control vaccine. Children 6 month old to 36 months old received 2 doses of 0.25 ml in an interval of 28 days. The vaccine was smoothly practised and well toleratedby the tested persons. No local reaction such as redness and swelling occurred at the injection site. The rate of low grade fever （37.1 ℃ - 37.5℃ ） in all subjects was 3.5%, all those were recovered within 48 hours . 100% initially seronegative subjects developed antibodies to the vaccine after vaccination. The HI geometric mean titers （ GMT） were increased 7.1 - 16.8 folds among insensitive subjects; the average fourfold rising rates （ FRR） of HI titers in antibodies were 73. 1% - 91.7%. The result demonstrated that the split-virus imfluenza vaccine was safe and maintained a good immunogenicity, and it was made by Lanzhou Institute of Biological Products.

关 键 词：流行性感冒裂解疫苗 临床试验 免疫效果 

分 类 号：R392[医药卫生—免疫学]