流行性感冒病毒裂解疫苗临床安全性及免疫原性研究

Evaluation on the Safety and Immunogenicity of Split Influenza Virus Vaccine

目的评价国产流行性感冒(流感)病毒裂解疫苗的安全性和免疫原性.方法在江苏省溧水县选择672名观察对象,按随机、双盲的抽样原则,以进口同类疫苗作为对照,开展现场临床试验.结果试验组接种1针后全身、局部反应发生率分别为2.92%、3.41%,临床反应率与对照疫苗(凡尔灵)相比差异无显著的统计学意义.血清学检测结果表明,两种疫苗除H3N2型对照疫苗优于试验疫苗外,其它两型差异无显著的统计学意义.两组疫苗易感者免疫后保护率达到94.9%以上,非易感者免疫后各型抗体呈≥4倍增长比例均＞45.9%;免疫后3个型抗体几何平均滴度增长了5.1～18.7倍.结论国产流感病毒裂解疫苗具有与进口同类疫苗类似的临床安全性;免疫后抗体阳转率较高,抗体滴度上升幅度较大,具有良好的免疫原性.

Objective To evaluate the safety and immunogenicity of domestic split influenza virus vaccine. Methods A random and double-blind study was carried out in Lishui, Jiangsu Province to compare the safety, seroconversion rates, and geometric mean titer （GMT） increase of the domestic split influenza vaccine with that of the same kind of vaccine imported from Aventis and Pasteur used as control. Results After immunization, the systemic and local reaction rates of domestic split influenza vaccine were 2.92 % and 3.41%, respectively, which was no statistically significant with control vaccine. Except a lower immunogenicity of H3N2 strain was observed in domestic split influenza vaccine than in control vaccine, no significant difference was found in the result of immunogenicity assay between the two vaccines.There were no less than 94.9% of susceptive subjects seroprotected, more than 45.9 % of no-susceptive subjects whose antibodies HI titers has four-foldrise and the HI geometric mean titers （GMT）were all increased 5.1-18.7 folds. Conclusion These clearly demonstrate that the domestic split influenza vaccine has same result in safety and immunogenicity compared with the imported vaccine.