季节性灭活流行性感冒病毒裂解疫苗在老年人中的免疫原性及与甲型H_1N_1流行性感冒病毒的交叉免疫研究

Immunogenicity of Trivalent Seasonal Influenza Vaccine(Split Virion)Inactivated in Elders and the Cross-reactive Immunity to Novel Influenza A(H_1N_1)Virus

目的评价与分析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]在老年人中应用的免疫原性,以及与甲型H1N1流感(甲流)病毒的交叉免疫。方法 2007年10～11月,在湖南省蓝山县进行开放式临床试验,受试者为140名61～75岁健康老人,接种疫苗后对受试者进行安全性观察,应用微量血凝抑制(Hemagglutination Inhibition,HI)试验对受试者血清进行抗体分型检测,同时检测和分析部分受试人群免疫前、后对甲流病毒的交叉免疫水平。结果 sInfV-Sp免疫后第21d,三个型别的HI抗体阳转率为72.3%～95.4%,抗体几何平均滴度(Geometric Mean Titer,GMT)增长8.0～41.1倍,保护率为90.0%～100.0%。其中易感人群免疫后,三个型别HI抗体阳转率显著高于非易感人群。该受试人群在sInfV-Sp免疫前、后针对甲流病毒的抗体保护率分别为8.6%和20.0%,免疫后抗体GMT增长倍数和阳转率分别为2.0倍和14.3%。此次试验的不良反应发生率为8.5%(12/140),以全身反应为主,未见严重不良反应。结论 sInfV-Sp在老年人接种后具有良好的免疫原性和安全性,同时能对甲流病毒产生一定的交叉免疫。

Objective To evaluate and analyze the immunogenicity of a trivalent seasonal influenza （split virion）inactivated vaccine in elders and its cross-reactive immunity to novel influenza A （H1N1） virus. Methods An open-labeled clinical trial was carried out in Lanshan county of Hunan Province from October to November 2003, 140 subjects aged from 61 to 75 years were enrolled. After vaccination, adverse events were observed and the different types antibodies of the subjects were tested by the micro-hemagglutination-inhibition （HI）test. Meanwhile, the preexisting and cross-reactive immunity against the novel influenza A（HlN1）virus were also detected and analyzed. Results A total of 8.6% of subjects （12/140）reported adverse reactions, and most of them were systemic reactions, no serious adverse reactions were reported. After receiving one dose of the vaccine, The seroconversion rates, GMT （geometric mean titer）ratios and seroprotection rates of HI antibody response to three types virus were 72.3% -95.4%, 8.0-41.1 and 90.0% - 100.0% respectively. The seroconversion rate in susceptible subjects is significant higher than that in non-susceptible subjects. The preexisting immunity against the novel influenza A （H1N1） virus were 8.6% and the seroprotection rate rises to 20.0% after administrated with the trivalent split influenza vaccine. GMT ratio and seroconversion rate were 2.0 and 14.3% respectively. Conclusion The vaccine has good safety and immunogenicty in elders, and it can induce a certain degree of cross-protection against the novel influenza A （ H1N1 ） virus.