Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Correlation between fecal microbiome diversity and seroconversion following influenza vaccination
研究概览
简要总结
This study evaluates the association between gut microbiome and dietary determinants and vaccine response. This study aims to learn if diet and the microbes (such as bacteria and viruses) found in your gut affect the body's immune response to the influenza vaccine.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the association of gut microbiome diversity with response to influenza vaccination as measured by vaccine-specific immune response.
SECONDARY OBJECTIVE:
I. To determine the gut microbial signatures and dietary patterns associated with response to influenza vaccination as measured by vaccine-specific post vaccine serum titers.
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •MD Anderson employees and student employees with existing MRN
- •Must be able to donate blood
- •Participants must be age 18 or older
- •Participants must receive the seasonal influenza vaccine at MD Anderson through Employee Health
- •Participants must consent to gut microbiome profiling, REDCap-based dietary screening questionnaire (Appendix A) and survey (Appendix B), and vaccine immune response testing which requires one stool sample, and two blood draws
排除标准
- •1. Participants with a contraindication to the recommended annual influenza vaccine
- •Pregnant women may be included in this study.
研究组 & 干预措施
Observational (questionnaire, biospecimen collection)
Participants complete questionnaires over 10-15 minutes up to 4 weeks prior to day of vaccination and undergo collection of blood samples up to 4 weeks before or on the day of vaccination and within 3 weeks post vaccination. Patients may also undergo collection of stool samples up to 4 weeks prior to day of vaccination.
干预措施: Biospecimen Collection (Procedure)
Observational (questionnaire, biospecimen collection)
Participants complete questionnaires over 10-15 minutes up to 4 weeks prior to day of vaccination and undergo collection of blood samples up to 4 weeks before or on the day of vaccination and within 3 weeks post vaccination. Patients may also undergo collection of stool samples up to 4 weeks prior to day of vaccination.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Correlation between fecal microbiome diversity and seroconversion following influenza vaccination
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点