国产流感裂解疫苗接种成人后的安全性和免疫原性观察

Safety and immunogenicity of domestic influenza virus split vaccine in adults

目的观察2012年变更毒株后生产的流感病毒裂解疫苗的安全性和免疫原性。方法选择江苏省泰州市高港区的344名18～60岁健康成人,接种上海生物制品研究所有限责任公司2012年7月生产的流感病毒裂解疫苗,观察疫苗接种后的临床反应情况;免疫前和免疫后42 d,收集免疫前后齐全的302人份血清,采用微量血凝抑制试验（HI）检测H1N1、H3N2和B 3个型别的血清抗体滴度,并计算血清抗体阳转率、保护率及抗体几何平均滴度（GMT）。结果接种疫苗72 h内,共发生4例（1.16%）轻度局部反应,未见全身反应,所有反应均为一过性反应,48 h内无需治疗,症状自行消失。免疫后H1N1、H3N2和B 3个型别的抗体保护率分别为98.01%、71.85%和99.67%,均明显高于免疫前（P均〈0.001）;免疫后3个型别的抗体阳转率分别为86.42%、65.23%和77.15%,抗体GMT分别为1︰339.70、1︰57.70和1︰460.89,比免疫前分别增长了16.36、6.02倍和5.26倍。结论 2012年变更毒株后生产的流感裂解疫苗临床安全性和免疫原性均较好。

Objective To observe the safety and immunogenicity of influenza virus split vaccine produced with alternative strain recommended by the WHO in 2012. Methods A total of 344 healthy adults in Gaogang District, Taizhou City,Jiangsu Province, at ages of 18 to 60 years, were immunized with influenza virus split vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. In July 2012, in whom the clinical reactions were observed. A total of 302 serum samples were collected before and after immunization, and determined for antibody titers against influenza virus of types H1N1, H3N2 and B by micro hemagglutination inhibition（HI） test, based on which serum antibody positive conversion rate, protective rate and GMT were calculated. Results Four cases（1. 16%）of mild local reactions were observed within72 h after immunization, while no systemic reactions found. All the reactions were transient, which disappeared within48 h without treatment. The protective rates of antibodies against types H1N1, H3N2 and B after immunization were 98. 01%,71. 85% and 99. 67% respectively, which were significantly higher than those before immunization（each P〈 0. 001）.However, the antibody positive rates against the three types were 86. 42%, 65. 23% and 77. 15%, while the GMTs were1 ∶ 339. 70, 1 ∶ 57. 70 and 1 ∶ 460. 89, respectively. The GMTs increased by 16. 36, 6. 02 and 5. 26 folds as compared with those before immunization respectively. Conclusion The influenza virus split vaccine produced with alternative strain recommended by the WHO in 2012 showed good safety and immunogenicity.