季节性灭活流行性感冒病毒裂解疫苗安全性和免疫原性及与甲型H_1N_1流行性感冒病毒的交叉免疫反应研究

Safety and Immunogenicity of Seasonal Inactivated Influenza Vaccine(Split Virion)and Cross-reactive Antibody Responses to the 2009 Pandemic H_1N_1 Influenza Virus

目的评价季节性灭活流行性感冒(流感)病毒裂解疫苗[Seasonal Influenza Vaccine(Split Virion),Inactivated;sInfV-Sp]的免疫原性及安全性,分析与甲型H1N1流感(甲流)病毒的交叉免疫反应。方法于2008年10月～2009年6月,在山东省青岛市开展开放式临床试验,选择18～60岁健康成人及>60岁健康老人接种sInfV-Sp进行安全性观察,并采集受试者免疫前及免疫后21d的血清标本,采用血凝抑制(Hemagglutination Inhibition,HI)试验检测sInfV三个型别抗体及甲流病毒抗体。结果 128名观察对象完成疫苗接种并进行安全性观察,其中120人完成采血。不良反应发生率为18.8%(24/128),以全身不良反应为主,发生率为12.5%(16/128),未见严重不良反应。接种疫苗后21d,成人组sInfV-Sp三个型别抗体阳转率为64.5%～90.3%,几何平均滴度(Geometric Mean Titer,GMT)增长5.1～26.8倍;老人组抗体阳转率为74.1%～84.5%,GMT增长5.7～28.4倍。两个年龄组免疫后甲流抗体阳转率为5.1%和8.2%,GMT增长1.4和1.7倍,明显低于sInfV-Sp(H1N1)水平。结论 sInfV-Sp免疫原性和安全性良好,与甲流病毒有一定交叉免疫反应。

Objective To evaluate the safety and immunogenicity of seasonal inactivated influenza vaccine （split virion）and to analyze its cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. Methods An open-labeled clinical trial was carried out in adults aged 18-60 years and elders aged 〉60 years. One dose of split influenza vaccine was administered and adverse events were observed. Serum samples were obtained before vaccination and 21 days after vaccination. Three types of antibody against seasonal influenza virus and antibody against 2009 pandemic H1N1 influenza virus were tested using microhemagglutination inhibition （HI）assay. Results A total of 128 subjects were recruited and serum samples were collected from 120 subjects. The overalI rate of adverse events was 18.8% （24/128）and most of them were systemic reaction. No serious adverse event was reported. After 21 days of vaccination, the seroconversion rate, Geometric Mean Titer （GMT） ratio （post/prevaecination） of antibody against seasonal influenza virus were 64.5 %-90.3 % and 5.1-26.8 among adults and 74.1%-84.5 %, 5.7-28.4 among elders respectively; the seroconversion rate, GMT ratio of antibody against 2009 pandemic H1N1 influenza virus among adults and elders were 5.1% and 8.2%, 1.4 and 1.7 respectively, which was significantly lower than the level of seasonal influenza H1N1 antibody. Conclusion The trial vaccine has good safety and immunogenieity and induced little cross-reactive antibody response to 2009 pandemic H1N1 influenza virus.