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目的评价国产流行性感冒裂解疫苗上市后的安全性与免疫原性。方法 2011年8~10月在河南省长葛、禹州和登封开展了多中心、随机、对照试验。6 171名观察对象随机分配到接种组(3 083人)和对照组(3 088人)。接种组每人接种一剂疫苗,对照组不接受任何处理,比较两组研究对象免疫后28 d不良反应发生率。在接种组随机抽取599人作为免疫效果评估对象,在免疫前和免疫后28 d,采用微量血凝抑制(HI)试验测定疫苗抗体。结果接种组全身和局部不良反应发生率分别为7.14%(220/3 083)和1.36%(42/3 083)。对照组全身不良反应发生率为1.17%(36/3 088),无局部不良反应发生。接种组全身和局部不良反应发生率均显著高于对照组(χ2=138.285,P<0.001;χ2=42.356,P<0.001)。接种组H1N1、H3N2及B型抗体阳转率分别为79.30%、82.80%和67.60%,抗体保护率分别为89.30%、98.30%和93.00%,GMT分别为1∶416、1∶796和1∶180。结论国产流行性感冒裂解疫苗具有良好的安全性和免疫原性,适宜推广应用。
Objective To evaluate the safety and immunogenicity of homemade influenza vaccine. Methods From August to October 2011, a multicenter, randomized, controlled trial was conducted in Changge, Yuzhou and Dengfeng, Henan Province. 6 171 subjects were randomized to inoculation group (3 083) and control group (3 088). Inoculation group vaccinated a dose of each, the control group did not receive any treatment, compared two groups of subjects 28 days after immunization adverse reactions. In the vaccination group randomly selected 599 people as the immune effect of the assessment of the object, before immunization and 28 d after immunization, the use of microagglutination inhibition (HI) test vaccine antibody. Results The incidence of systemic and local adverse reactions in vaccinated group were 7.14% (220/3 083) and 1.36% (42/3 083), respectively. The incidence of systemic adverse reactions in the control group was 1.17% (36/3 088), no local adverse reactions occurred. The incidence of systemic and local adverse reactions in vaccinated group were significantly higher than those in control group (χ2 = 138.285, P <0.001; χ2 = 42.356, P <0.001). Inoculation group H1N1, H3N2 and B type antibody positive conversion rates were 79.30%, 82.80% and 67.60%, antibody protection rates were 89.30%, 98.30% and 93.00%, GMT were 1: 416, 1: 796 and 1: 180. Conclusion The domestic influenza lysis vaccine has good safety and immunogenicity, suitable for popularization and application.