Infectivity of Norovirus in Groundwater-Human Challenge Study
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| First Received Date ICMJE | April 10, 2006 | ||||||||||||
| Last Updated Date | March 30, 2012 | ||||||||||||
| Start Date ICMJE | February 2006 | ||||||||||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Infection with norovirus [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00313404 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Infectivity of Norovirus in Groundwater-Human Challenge Study | ||||||||||||
| Official Title ICMJE | Assessment of Calicivirus Survival in Surface Water and Subsurface Water | ||||||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE | Healthy | ||||||||||||
| Intervention ICMJE | Biological: Safety tested norovirus inoculum
This is a safety tested live infectious norovirus inoculum that has been placed in groundwater that meets EPA drinking water standards
Other Name: Norwalk virus in groundwater |
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| Study Arm (s) | Experimental: 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.
Intervention: Biological: Safety tested norovirus inoculum |
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| Publications * | 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. Epub 2011 Aug 19. | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 13 | ||||||||||||
| Completion Date | April 2011 | ||||||||||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 50 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00313404 | ||||||||||||
| Other Study ID Numbers ICMJE | RSPHGH-CLM-2005-EPANoV, EPA-5 R01 AI056351-03, 82911601-1 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Christine Moe, PhD, Emory University | ||||||||||||
| Study Sponsor ICMJE | Emory University | ||||||||||||
| Collaborators ICMJE | Johns Hopkins University | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||||||||||
| Verification Date | March 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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