Immune and Genetic Correlates of Response to Zoster Vaccine in the Frail Elderly: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly
研究概览
简要总结
This study is being done to evaluate the zoster vaccine response in the nursing home elderly (80 years or older). As the immune system ages, the response to vaccines is not always as strong as in younger people. Previous zoster vaccine studies have excluded nursing home residents so the vaccine effect in this population is not known. Furthermore, the immune and genetic reasons as to why the vaccine works well in some people but not in others are also unknown. The goal of this study is to evaluate why some immune systems respond well to the vaccine and why others do not.
详细描述
Deleterious changes in immunity that occur with aging are known as immunosenescence. Such changes, particularly in adaptive immunity, may lead to an impaired vaccine response in the elderly. Characterizing the immune determinants and the genetic basis for vaccine response in the frail elderly is a practical approach to better our understanding of immunosenescence. Data on genetic determinants to immunization are sparse, furthermore, to the best of our knowledge, none exist in the elderly. In this pilot study, we propose studying the immune response to the herpes zoster vaccine and the underlying genetic determinants of the immune response in elderly residents of nursing homes.
The three specific aims of this study are to generate data in order to 1) assess the T-cell response to the varicella-zoster virus (VZV) vaccine in the frail elderly; 2) assess whether immune (T-cell) phenotypes are associated with a response; 3) test the association between immune response genotype sets and T-cell response. We hypothesize that response to the VZV vaccine in elderly nonambulatory nursing home residents is a function of characteristic T-cell immune phenotypes prior to vaccination and that there are immune genetic polymorphisms associated with the response. This study will allow us to generate preliminary data and establish feasibility in order to address these questions fully in a larger population in a subsequent grant application.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nursing home resident
- •greater than or equal to 80 years old
- •non-ambulatory
排除标准
- •less than 80 years old
- •ambulatory
- •taking immunosuppressive medication
- •history of primary or acquired immuno-deficiency states including leukemia, other malignant neoplasms affecting the bone marrow or lymphatic system, and AIDS
- •active untreated tuberculosis
- •previous receipt of varicella vaccine
- •residents expected to expire within 30 days, in the opinion of the most responsible physician
- •residents planning to move nursing homes within the year
- •temporary residents
研究组 & 干预措施
Nursing Home Elderly Cases
Non-ambulatory nursing home residents >= 80 years old will be vaccinated with the zoster vaccine and provide baseline and post-vaccination blood samples. We will assess differences in genotype frequencies between participants with high and low RCF and ELISPOT responses using a candidate gene approach with SNPs (single nucleotide polymorphisms). A case will be considered failure to mount a high response.
干预措施: Zostavax (Drug)
Nursing Home Elderly Controls
Non-ambulatory nursing home residents >= 80 years old will be vaccinated with the zoster vaccine and provide baseline and post-vaccination blood samples. We will assess differences in genotype frequencies between participants with high and low RCF and ELISPOT responses using a candidate gene approach with SNPs. A control will be a participant who mounted an adequate response as defined in primary outcomes.
干预措施: Zostavax (Drug)
Community dwelling seniors
Community dwelling seniors ages 60-75 will be enrolled as a control group for the laboratory testing. They will be vaccinated and will provide pre- and post-vaccination blood. If nursing home residents do not show a response it is important to know that it is not a failure of the laboratory's measurement of immunogenicity.
干预措施: Zostavax (Drug)
结局指标
主要结局
Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly
时间窗: 6 weeks
As the primary phenotype, we will compare change in Enzyme-linked immunosorbent spot (ELISPOT) from baseline (i.e., pre and post vaccination). A high baseline T cell response will be defined as ELISPOT = \>50 spots and a low baseline response will be ELISPOT = \<10 spots.
Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio
时间窗: Baseline
Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.
Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells
时间窗: Baseline
Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.
次要结局
未报告次要终点