CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Percentage of Responders
研究概览
简要总结
This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine. Patients having standard-of-care colonoscopies will be divided into 3 groups:
Group 1: Vivotif typhoid vaccination then colonoscopy; Group 2: Colonoscopy, then Vivotif typhoid vaccination, then follow-up colonoscopy; Group 3: Colonoscopy without vaccination.
The Vivotif typhoid vaccine used in this study is licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Age 18 years and older
- •Undergoing colonoscopy for screening or surveillance for colorectal cancer at the University of Maryland
- •Provide written informed consent prior to initiation of any study procedures
- •Healthy, as defined by considered fit to undergo outpatient elective colonoscopy by the referring health care provider
排除标准
- •Pregnancy or nursing mother
- •Known coagulopathy or bleeding disorder preventing mucosal biopsy
- •History of Crohn's disease or ulcerative colitis
- •Surgical removal of the ileocecal valve or any part of the small or large intestine
- •Allergic reaction to oral typhoid vaccine in the past
- •Immunosuppression from illness or treatment, including
- •immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
- •leukemia, lymphoma, or cancers
- •immune suppressive medications or treatments, such as corticosteroids or radiation
- •Receipt of any other vaccine two weeks prior to receipt of Ty21a
- •Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination
研究组 & 干预措施
Vaccination, Colonoscopy
Individuals receive immunization with Vivotif typhoid vaccine prior to routine colonoscopy examination. During colonoscopy, small bowel biopsies will be obtained to examine immune responses and microbiota at the mucosal level; brushings will also be obtained.
干预措施: Vivotif Typhoid Oral Vaccine (Drug)
Colonoscopy, Vacciniation, Colonoscopy
Individuals receive immunization with Vivotif typhoid vaccine after initial colonoscopy exam and specimen collection and prior to a routine follow up colonoscopy examination during which additional specimens will be collected.
干预措施: Vivotif Typhoid Oral Vaccine (Drug)
Colonoscopy Without Vaccination
Individuals do not receive immunization but consent to collection of specimens during colonoscopy. The specimens to be collected in all three groups include stool, saliva, and small bowel biopsies (terminal ileum).
结局指标
主要结局
Percentage of Responders
时间窗: approximately 5 years
Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry. Responders will be defined as those volunteers showing increases post-immunization of \>0.1% of positive CD8+ cells for IFN-gamma or TNF-α over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry.
次要结局
未报告次要终点
研究者
Bruce Greenwald
Professor of Medicine
University of Maryland, Baltimore