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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0.25m l,间隔28天;成人接种0.5 m l。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H I抗体总阳转率为100%,非易感人群的H I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。
Lanzhou Institute of Biological Products developed influenza virus lysis vaccine in September 2003 to December in Guangxi Ⅰ ~ Ⅲ clinical trials to evaluate the safety and immunogenicity of the vaccine assessment. A total of 852 people (6 months to 67 years) were vaccinated with the test vaccine and 227 were vaccinated with the control vaccine. 6 to 36 months old infants were vaccinated 2 needles, each 0.25m l, an interval of 28 days; adult 0.5ml. All inoculated subjects showed no local reactions such as inflamed or indurated fibrosis. The incidence of hypothermia (37.1 ℃ ~ 37.5 ℃) was 3.5%, which returned to normal within 48 hours. The total positive rate of H I antibody in susceptible population after vaccination was 100%. The geometric mean titer of H I antibody in non-susceptible population increased 7.1 ~ 16.8 times, and the antibody 4-fold growth rate was 73.1% -91.7%. The vaccine proved to have good safety and immunogenicity.