文章摘要
王萍,张昕伟,宋宇飞,殷洪博,刘丽杰,车雷,李辉,刘研,陈江婷.流行性感冒病毒裂解疫苗在18岁以上健康人群中应用的安全性及免疫原性研究[J].中华流行病学杂志,2011,32(2):120-124
流行性感冒病毒裂解疫苗在18岁以上健康人群中应用的安全性及免疫原性研究
Safety and immnnogenicity on the formulation of trivalent split influenza vaccine among healthy people aged over 18 years
收稿日期:2010-10-26  出版日期:2014-09-10
DOI:
中文关键词: 感病毒裂解疫苗;成人剂型;免疫原性;安全性
英文关键词: plit influenza vaccine;Adult formulation;Immunogenicity;Safety
基金项目:
作者单位E-mail
王萍 沈阳市疾病预防控制中心, 110031  
张昕伟 北京科兴生物制品有限公司  
宋宇飞 北京科兴生物制品有限公司  
殷洪博 沈阳市疾病预防控制中心, 110031  
刘丽杰 沈阳市疾病预防控制中心, 110031  
车雷 沈阳市疾病预防控制中心, 110031  
李辉 北京科兴生物制品有限公司  
刘研 北京科兴生物制品有限公司  
陈江婷 北京科兴生物制品有限公司 chenjt@sinovae.Com 
摘要点击次数: 2017
全文下载次数: 811
中文摘要:
      目的 评价流感病毒裂解疫苗安尔来福?的免疫原性及安全性. 方法 2010年8-9月在沈阳市开展开放式临床试验,选择18~60岁及>60岁健康成年人接种安尔来福?进行安全性观察,并采集受试者免疫前及免疫后21 d 血清标本,采用血凝抑制试验(HI)进行流感病毒裂解疫苗甲型H1N1、甲型H3N2及乙型3个型别抗体检测. 结果 130名观察对象完成疫苗接种并进行安全性观察,其中120人完成免疫前及免疫后采血.总体不良反应发生率为2.3%(3/130),均为全身不良反应,未出现严重不良反应.接种疫苗后21 d,成年组甲型H1N1、甲型H3N2及乙型3个型别抗体阳转率分别为82.5%、93.7%、92.1%,GMT增长倍数分别为20.2、32.0、11.4,保护率分别为92.1%、98.4%、98.4%;老年组3个型别抗体阳转率分别为89.5%、91.2%、87.7%,GMT增长倍数分别为23.9、39.8、15.1,保护率分别为93.0%、94.7%、96.5%. 结论 疫苗安尔来福?接种后甲型H1N1、甲型H3N2及乙型3个型别抗体各项指标均超过欧盟标准,表明其免疫原性及安全性良好.
英文摘要:
      Objective To evaluate the safety and immunogenicity of split influenza vaccine (Anflu? ). Methods An open-labeled clinical trial was carried out in adults aged 18-60 years and elders aged over 60 years from August to September, 2010 in Shenyang, Liaoning province. One dose of split influenza vaccine was administered and adverse events were observed. Serum samples were obtained prior to vaccination and 21 days post vaccination. A/H1N1, A/H3N2 and B antibodies against influenza virus were measured using micro-hemagglutination inhibition (HI) assay. Results A total of 130 subjects were recruited and 120 paired serum samples were obtained. The overall rate of adverse events was 2.3% (3/130) and all of them with systemic reaction. No single serious adverse event was reported. 21 days after the vaccination, the sero-conversion rates of A/H1N1, A/H3N2 and B antibodies against influenza virus among adults were 82.5%, 93.7% and 92.1%, respectively. The Geometric Mean Titer (GMT) ratios were 20.2, 32.0 and 11.4, while the sero-protection rates were 92.1%, 98.4% and 98.4%, respectively. The sero-conversion rates of antibodies among elders were 89.5%, 91.2% and 87.7%, with the GMT ratios as 23.9, 39.8 and 15.1, respectively. The seroprotection rates were 93.0%, 94.7% and 96.5%,respectively. Conclusion All indexes ofA/H1N1,A/H3N2 and B antibodies exceeded the licensure criteria established by the EU Committee for Medicinal Products for Human Use,proving the trial vaccine Anflu? with good safety and immunogenicity.
查看全文   Html全文     查看/发表评论  下载PDF阅读器
关闭