流行性感冒病毒裂解疫苗的安全性和免疫原性研究

目的 研究流行性感冒(流感)病毒裂解疫苗的安全性和免疫原性。方法 根据国家食品药品监督管理局2002SL0043号《新药临床研究申请批件》的要求，选择876例观察对象按随机双盲法分成试验组和对照组，观察局部反应和全身反应。用微量血凝抑制(H1)试验检验抗体应答反应，计算抗体阳转率、保护率及几何平均滴度(GMT)增长倍数。结果 试验疫苗和对照疫苗间全身和局部不良反应发生率差异无显著意义；两组间H1抗体阳转率、保护率及H3N2亚型和B型H1抗体GMT增长倍数差异无显著意义；然而，两种疫苗H1N1亚型的H1抗体GMT增长倍数间差异有显著意义。结论 两种疫苗均具有很好的安全性和免疫原性。

Safety and immunogenicity of split vaccines of influenza viruses

OBJECTIVE: To evaluate the safety and immunogenicity of influenza split vaccine. METHODS: According to the criteria of No.2002SL0043, instruction of application for new drug in clinical trial issued by the State Food and Drug Administration, 876 healthy persons were divided at random into vaccine group and control group. The trial was performed with the double blind method. Local and systemic adverse reactions were observed within 3 days after the vaccine group subjects were vaccinated. The antibody response to vaccines was detected with hemagglutination inhibition (HI) test. Numbers of seroconversions and HI titers greater than or equal to 40, as well as the mean geometric titer increase in HI were analyzed. RESULTS: There was no significant difference in local and systemic adverse reaction between vaccine and control groups. Meanwhile there was also no significant difference in seroconversions and protective level between two groups. However, there was obvious difference in mean geometric titer increase of antibody against H1N1 virus, while there was no significant difference in that of antibodies to H3N2 and type B viruses. CONCLUSIONS: The safety and immunogenicity of both vaccines are excellent.