国产流行性感冒病毒裂解疫苗上市后的安全性及免疫原性评价

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。

Post-marketing evaluation on the safety and immunogenicity of domestic split influenza virus vaccine

Objective To evaluate the safety and immunogenicity of post-marketing domestic split influenza virus vaccine. Methods A multicenter, randomized, controlled clinical trial was conducted in Changge, Yuzhou and Dengfeng, Henan province during August- October, 2011.6 171 healthy persons were divided into vaccine group and control group randomly. Each one was inoculated one dose of vaccine in vaccination group. The control group did not receive any treatment. The adverse reaction rates between vaccination group and control group were compared. In vaccination group, 599 cases were randomly selected as evaluation objects for immune effects. The blood samples were collected before immunization and 28 days after immunization. The antibodies were measuredby hemagglutination inhibition （HI） test. Results The systemic and local reaction rates in vaccinatioh group were 7.14 % （220/3083） and 1.36 %（42/3083）. Systemic reaction rate in control group was 1.17 % （36/3088）. There was no local reaction in control group. The systemic and local reaction rates in vaccination group were significantly higher than those in control group （X2=138.285, P〈0.001X2=-42.356, P〈0.001 ）. The antibody positive rates of H1N1, H3N2 and B in vaccine group were 79.30 %, 82.80 and 67.60 %, respectively. The antibody protective rates of H1N1, H3N2 and B were 89.30 %, 98.30 % and 93.00 %, respectively. The geometric mean titers were 1 ： 416, 1 ： 796 and 1 ： 180, respectively. ConclusionsThe domestic influenza split vaccine has good safety and immunogenicity, and might be suitable for mass vaccination.