Single Cell Molecular Analysis of Influenza Vaccine Induced T Cell Responses in Adults 65 Years of Age or Older
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Hemagglutinin Antigen Inhibition Assay Titers at Day 28
研究概览
简要总结
To study the effects of age on the immune system's response to flu vaccine and to study the connection between the immune system and physical and cognitive changes associated with aging.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
This is an open label trial, the study nurse and participant know which of 3 FDA approved influenza vaccines are given (Fluzone-HD, FluAd, or Flublok). However the investigator and outcomes assessor are blinded to the actual vaccine given.
入排标准
- 年龄范围
- 65 Years 至 125 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years and over
- •Independent Living (including Assisted Living)
排除标准
- •Unable to understand the consent or the study.
- •Allergic to any vaccine components, excluding eggs.
- •History of Guillain-Barre.
- •Residing in a long -term care facility such as a nursing home.
结局指标
主要结局
Hemagglutinin Antigen Inhibition Assay Titers at Day 28
时间窗: Day 28 Baseline
2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
Hemagglutinin Antigen Inhibition Assay Titers at Baseline
时间窗: Baseline Baseline
2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
次要结局
未报告次要终点
研究者
Spyros Kalams
Associate Professor Infectious Disease
Vanderbilt University Medical Center