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临床试验/JPRN-UMIN000007461
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The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human. - The detection and analysis of neutralizing antibodies in nasal mucosa induced by intranasal administration of an inactivated whole-virus vaccine (H3N2 virus) in human.

ational Institute of Infectious Diseases0 个研究点目标入组 50 人开始时间: 2012年3月7日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
50

研究概览

简要总结

Haemagglutination inhibition (HI) and neutralization (NT) titres as well as haemagglutinin (HA) specific antibody responses were examined in 50 healthy adults aged between 22 and 69 years old after two intranasal administrations of an inactivated A/Victoria/210/2009 whole virus vaccine (45 ug HA per dose) at 3 week intervals. Serum HI titres after two-doses of the nasal vaccine showed >2.5-fold rise in the ratio of geometric mean titre upon vaccination, >40% of subjects with a >4-fold increase in titre and >70% of subjects with a titre of >1:40, all parameters associated with an effective outcome of vaccination in the criteria defined by the European Medicines Agency. Serum neutralizing antibody responses correlated with HI antibody responses, although NT titres were about two-fold higher than HI titres. These high levels of serum responses were accompanied by high levels of HI and neutralizing antibody responses in nasal mucus as measured in concentrated nasal wash samples that were about 10 times diluted compared to natural nasal mucus. Serum and nasal HI and neutralizing antibody responses consisted of HA-specific IgG and IgA antibody responses, with IgG and IgA antibodies being dominant in serum and nasal responses, respectively. Hum Vaccin Immunother. 2013 Sep 1;9(9):1962-70. doi: 10.4161/hv.25458.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 70years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1. Volunteers with a fever at the time of planned vaccination. 2. Volunteers with serious acute diseases. 3. Volunteers considered inappropriate to be inoculated vaccine.

研究者

发起方
ational Institute of Infectious Diseases

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