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临床试验/NCT00902278
NCT00902278已完成不适用

Immune Response Induced by Different Manufacturers of Influenza Vaccines

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2008年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
193
试验地点
2
主要终点
T Cell Responses Following Immunization

研究概览

简要总结

The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.

详细描述

There are currently five licensed inactivated influenza vaccines approved for use in the United States by the Food and Drug Administration.Current influenza virus vaccines consist of 3 components: the HA protein from an H1N1 virus, an H3N2 and an influenza B virus.Influenza vaccines are evaluated and approved by the FDA on the basis of HA and NA content. However, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of HA protein but different patterns of influenza influenza internal proteins such as NP and M1. The presence of these additional internal proteins of influenza virus which are targets of T cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of T cell mediated protection between different manufacturers of commercial influenza vaccines.Each subject will have four blood samples taken- prevaccination and at Days 7, 14,30 and 3-5 months post vaccination. These samples will be tested for T and B cell responses and the results compared between different manufacturers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18-50 years of age)
  • Willing to donate a blood sample multiple times
  • Willing to sign informed consent and HIPAA

排除标准

  • Known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins
  • Known hypersensitivity to neomycin, thimerosol (mercury derivative), neomycin, or polymyxin
  • Previous life threatening reaction to influenza vaccine
  • Individuals with altered immunocompetence state from medical condition ( HIV, cancer) or through immunosuppressive therapy(irradiation,corticosteroids, antimetabolites, alkylating agents, cytotoxic agents)
  • Occurrence of neurological syndrome within six weeks of previous influenza immunization
  • Active neurological disorder characterized by changing neurological disorder
  • Pregnancy
  • Acute febrile illness
  • History of anemia or bleeding disorders

研究组 & 干预措施

Flulaval

Active Comparator

干预措施: Flulaval (Biological)

Fluvirin

Active Comparator

干预措施: Fluvirin (Biological)

Fluzone

Active Comparator

干预措施: Fluzone (Biological)

Fluarix

Active Comparator

干预措施: Fluarix (Biological)

Affluria

Active Comparator

干预措施: Afluria (Biological)

结局指标

主要结局

T Cell Responses Following Immunization

时间窗: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination

Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups

次要结局

  • Antibody Responses Following Immunization(Prevaccination and approximately 1 month post vaccination)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Co

Study Principle Investigator

University of Massachusetts, Worcester

研究点 (2)

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