国产流感裂解疫苗接种人体后安全性和免疫原性评价

Evaluation on the safety and immunogenicity of domestic split influenza virus vaccine after inoculation

目的:评价变更后流感毒株生产的国产流感裂解疫苗安全性和免疫原性。方法:对宁波市宁海县559例分组接种流感裂解疫苗者进行临床指标(局部反应、全身反应)的监测,并抽取其中213例,用流感病毒HI抗体测定法对接种者免疫前后的抗体滴度进行测定,比较免疫前后抗体阳转率及几何平均滴度(GMT)。结果:观察对象接种疫苗后发热反应发生率为1.22%,全身其他反应发生率为1.22%,局部反应发生率为1.07%,且以轻度反应为主。H1N1型、H3N2型、B型免后抗体阳转率分别为84.04%、85.45%、83.57%;不同年龄组免后抗体滴度的增长倍数,H1N1型在5.50～16.00倍之间,H3N2型在13.16～39.33倍之间,B型在7.28～24.85倍之间,各年龄组各抗体型别免疫前后GMT差别均有统计学意义。结论:国产流感裂解疫苗具有良好的安全性和免疫原性。

Objective： To evaluate the safety and immunogenicity of domestic split influenza virus vaccine made from the changed influenza virus. Methods： 559 subjects inoculated flu vaccine in Ninghai county were selected, to observe clinical reaction （systemic reaction and local reaction）. 213 samples of them were chosen to measure the antibody titer by anti - HI assay of influenza virus and then the antibody positive conversion rates and GMTs before and after inoculating were compared. Results： After injection, fever rate was 1.22%, other systemic reaction rate was also 1.22%, and local reaction rate was 1.07%, and the majority of the people with adverse reaction were mild. The positive conversion rates of antibodies of type H1N1 ,H3N2 and B were 84.04% , 85.45% , 83.57% respectively. Among different ages, the anti - HI GMT of H1 N1 strain, H3N2 strain, B strain increased between 5.50 - 16.00, 13.16 - 39.33 and 7.28 - 24.85 folds respectively. The GMT before and after inoculation.had significant difference among different ages and antibody types. Conclusion： Domestic split - virion influenza vaccine has excellent safety and immunogenicity.