甲型H1N1流感疫苗安全性和免疫原性初步研究  

Safety and immunogenicity of influenza A(H1N1) 2009 vaccine

作　　者：庄茂欣[1] 潘红星[2] 王芙 崔颖杰[1] 姜葳[1] 张雪峰[2] 孟繁岳[2] 姚根红[4] 周余春 胡小奎 朱凤才[2] 

机构地区：[1]长春生物制品研究所,吉林长春130062 [2]江苏省疾病预防控制中心,江苏南京210009 [3]中国生物技术集团公司,北京100029 [4]泰兴市疾病预防控制中心,江苏泰兴225400

出　　处：《东南大学学报（医学版）》2009年第6期459-463,共5页Journal of Southeast University(Medical Science Edition)

摘　　要：目的：评价国产甲型H1N1流感病毒裂解疫苗的临床安全性和免疫原性。方法：按照随机、对照、盲法的原则，选择老年（60岁以上）组、少年（12～17岁）组和少儿（3～11岁）组各220人，按1：1比例随机接种15、30μg甲型HH1N1流感疫苗；成年（18～60岁）组330人，按1：1：1比例随机接种15、30μg甲型H1N1流感疫苗和安慰剂对照。比较两种剂量疫苗免后总体不良反应率、全身和局部不良反应率、HI抗体阳转率、HI抗体（≥1：40者）保护率、免后HI抗体GMT和免后HI抗体GMT较免前平均增长倍数。结果：免后21d，各剂量组征集性不良反应总发生率为10．81％（107／990），均以1级不良反应为主，未观察到3级及以上不良反应。安全性观察期内未观察到其它异常反应、偶合反应和任何有临床意义的严重不良事件。30、15μg的HI抗体阳转率分别为87．24％、84．45％，差异无显著性，均显著高于安慰剂对照组的HI抗体阳转率；HI抗体（≥1：40者）保护率分别为87．94％和85．61％，差异无显著性，均显著高于安慰剂对照组的HI抗体保护率；免后HI抗体GMT 30μg组高于15μg组，15μg组高于安慰剂对照纽，且差异均有显著性，其中12～17岁组和〉60岁组免后抗体GMT水平30μg组均高于15μg组，且差异均有显著性；30、15μg两个剂量组间免后HI抗体GMT较免前平均增长倍数差异无显著性，与安慰剂对照组差异有显著性。结论：此国产甲型H1N1流感病毒裂解疫苗具有良好的安全性和免疫原性。Objective To evaluate safety and immunogenicity of influenza A （H1N1） 2009 vaccine. Methods Samples were chosen by cluster and random method. A total of 990 subjects, years, 12 15 μg he 17 years, 18 - 60 magglutinin antigen yesrs and 〉 60 or PBS （placebo） nation-inhibitionand assays at baseline and 21 equally divided into 4 age groups （3 - 11 by intramuscular injection. We measured antibody titers using hemagglutidays after vaccination. The coprimary immunogenicity end points were the antibody positive rates and the proportion of subjects with antibody titers of 1 ： 40 or more on hemagglutination-inhibition assay,the proportion of subjects with either seroconversion or a significant increase in antibody titer, and the factor increase in the geometric mean titer. Results By day 21 after vaccination, the general adverse event of 30 μg dose and 15 μg dose did not appeared statistically significant, and the level of adverse event were also not appeared statistically significant. No death, serious adverse events, or adverse events of special interest were reported. Antibody positive rates were observed in 364 of 431 （84.45%） subjects who received the 15 μg dose and in 376 of 431 subjects （87.24%） who received the 30 μg dose, antibody titers of 1：40 or more were observed in 369 of 431 subjects （85.61%） who received the 15 μg dose and in 379 of 431 subjects （87.94%） who received the 30 μg dose as well. Conclusion A single 15 μg or 30μg dose of 2009 HIN1 vaccine is immunogenic in people whose age is above 3 years, especially in adults, with mild- to- moderate vaccine- associated reactions.

关 键 词：甲型H1N1流感疫苗 安全性 免疫原性 

分 类 号：R511.7[医药卫生—内科学] R392.2[医药卫生—临床医学]