国产流感病毒亚单位疫苗的安全性及免疫原性

Safety and immunogenicity of domestic influenza virus subunit vaccine

目的观察国产流感病毒亚单位疫苗的安全性及免疫原性。方法按照单盲法、随机、对照的原则,将900名观察对象分为幼儿组、儿童组、成人组和老年组,各组分别按2∶1的比例随机接种试验疫苗和对照疫苗(进口疫苗),观察各组接种后的全身反应、局部反应和其他不良反应以及免疫后HI抗体阳转率、保护率和GMT增长倍数。结果观察组接种后全身反应发生率为8.33%,仅1例发生局部反应,不同年龄人群全身反应发生率与对照组相比,差异均无统计学意义(P>0.05);免疫后观察组H1N1、H3N2和B(亚)型HI抗体总阳转率分别为87.90%、70.02%和71.32%,保护率分别为93.30%、93.30%和74.67%,与对照组相比,差异均无统计学意义(P>0.05);GMT增长倍数分别为31.6、8.2和14.0,除H1N1亚型GMT平均增长倍数高于对照组外,其他两(亚)型与对照组相比,差异无统计学意义(P>0.05)。结论国产流感病毒亚单位疫苗具有与进口同类疫苗相似的安全性和免疫原性。

Objective To observe the safety and immunogenicity of domestic influenza virus subunit vaccine.Methods A randomized,blind and control trial was performed in 900 healthy persons who were divided into infant,child,adult and aged groups.Two-third of subjects in each group were inoculated with trial vaccine（domestic）,while one-third with control vaccine（imported）.The systemic and local reactions as well as other adverse events in various groups were observed,while the HI antibody positive rates,protective rates and increasing folds of GMTs were determined.Results Total systemic adverse reaction rate after inoculation with trial vaccine was 8.33%,while only one case of local adverse reaction was observed.The systemic adverse reaction rates of subjects inoculated with trial vaccine in various groups showed no significant difference with those with control vaccine（P 〉 0.05）.The total HI antibody positive rates against influenza virus（sub）types H1N1,H3N2 and B induced by trial vaccine were 87.90%,70.02% and 71.32%,while the protective rates were 93.30%,93.30% and 74.67%,respectively,which showed no significant difference with those induced by control vaccine（P 〉 0.05）.The GMTs of antibodies against influenza virus（sub）types H1N1,H3N2 and B induced by trial vaccine increased by 31.6,8.2 and 14.0 folds respectively.The increasing fold of antibody against H1N1 virus induced by trial vaccine was higher than,while those against H3N2 and B viruses showed no significant difference with those by control vaccine（P 〉 0.05）.Conclusion Both the safety and immunogenicity of domestic influenza virus subunit vaccine were comparable to those of imported vaccine.