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临床试验/NCT01244802
NCT01244802Enrolling By Invitation不适用

Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

Emory University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
1
主要终点
Determine the phenotypic and functional characterization of memory T cell responses to YF vaccination

研究概览

简要总结

The objective of this study is to study immune memory generated against the yellow fever (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not receive vaccine shots; only immune responses to previous yellow fever vaccination will be studied. The study involves one or multiple blood draws.

详细描述

The goal of this study is to characterize immune memory in humans who have previously received yellow fever vaccine. The project is designed to study the magnitude and persistence of both humoral, and cell-mediated immune memory generated post-vaccination. Since aging has an effect on the immune system (eg. decreased thymic output, replacement of hematopoietic cells in the bone marrow with adipocytes), the researchers will analyze the young adults (aged 18-45 years) and the older vaccinees (55 years or older) in separate groups.

The specific aims of the study are to:

  • Determine the phenotypic and functional characterization of memory T cell responses to yellow fever vaccination
  • Determine neutralizing antibody titer after yellow fever vaccination

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • Able to understand and give informed consent
  • Age 18-45 years (Group 1) or 55 years and above (Group 2) at the time of yellow fever vaccination
  • Documentation (international certificate of vaccination (yellow card) or medical record) indicating receipt of yellow fever vaccine.

排除标准

  • Recipient of any vaccines within 30 days before the study visit (not applicable to older adults)
  • History of a progressive and severe chronic medical condition resulting in impaired immunity (such as diabetes, kidney or liver dysfunction)
  • Required use of immunosuppressive medications
  • Reporting HIV, Hepatitis B (surface antigen positive) or Hepatitis C infections (antibody positive) on the medical/health history form
  • Recipient of a blood product or immune globulin product within 42 days of study visit
  • Reporting pregnancy

结局指标

主要结局

Determine the phenotypic and functional characterization of memory T cell responses to YF vaccination

时间窗: Immune responses will be measured from at least 30 days after yellow fever vaccination.

This is an exploratory analysis of variation in immune response with time since last yellow fever virus vaccination.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sri Edupuganti

Professor

Emory University

研究点 (1)

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