Infectivity of Norovirus in Groundwater-Human Challenge Study
Assessment of Calicivirus Survival in Surface Water and Subsurface Water
Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States. These viruses are sometimes found in drinking water, ice, shellfish and in other foods. They can be spread easily from contact with water, food, objects or hands that have even small amounts of feces from someone who was sick.
The purpose of this research study is to see how long Norwalk virus can survive in water and still be able to cause sickness. When this is determined the researchers will be able to recommend risk levels for norovirus contaminated waters. Another purpose for this study is to see how a person's body's immune cells respond to Norwalk virus in the body. During this study volunteers will receive a dose of Norwalk virus in water that may make them sick.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University General Clinical Research Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Normal healthy volunteer
- Must be within 33% of normal body mass index
Exclusion Criteria:
- Have a job in which they handle food
- Work in a child care, elderly care center or if they live with young children or anyone who has a weak immune system
- Are not willing or able to wash their hands every time after they go to the bathroom, or before and after they prepare or handle food for up to eight days after they take the virus
- Are over the age of 50
- Are pregnant
- Have tested positive for the HIV virus
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Norovirus in groundwater
We dosed volunteers with safety tested infectious norovirus in groundwater (that met EPA standards for drinking water).
The length of time norovirus remained in groundwater varied by volunteer.
|
This is a safety tested live infectious norovirus inoculum that has been placed in groundwater that meets EPA drinking water standards
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Infection with norovirus
大体时间:Throughout study
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Throughout study
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合作者和调查者
调查人员
- 首席研究员:Christine Moe, PhD、Emory University
- 首席研究员:George M Lyon III, MD, MMSc、Emory University
- 首席研究员:Kellogg Schwab, PhD、Johns Hopkins University
出版物和有用的链接
一般刊物
- Seitz SR, Leon JS, Schwab KJ, Lyon GM, Dowd M, McDaniels M, Abdulhafid G, Fernandez ML, Lindesmith LC, Baric RS, Moe CL. Norovirus infectivity in humans and persistence in water. Appl Environ Microbiol. 2011 Oct;77(19):6884-8. doi: 10.1128/AEM.05806-11. Epub 2011 Aug 19.
- Williams AM, Ladva CN, Leon JS, Lopman BA, Tangpricha V, Whitehead RD, Armitage AE, Wray K, Morovat A, Pasricha SR, Thurnham D, Tanumihardjo SA, Shahab-Ferdows S, Allen L, Flores-Ayala RC, Suchdev PS. Changes in micronutrient and inflammation serum biomarker concentrations after a norovirus human challenge. Am J Clin Nutr. 2019 Dec 1;110(6):1456-1464. doi: 10.1093/ajcn/nqz201.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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