Infectivity of Norovirus in Groundwater-Human Challenge Study

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Christine Moe, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00313404
First received: April 10, 2006
Last updated: November 18, 2013
Last verified: November 2013

April 10, 2006
November 18, 2013
February 2006
January 2007   (final data collection date for primary outcome measure)
Infection with norovirus [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00313404 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Healthy
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
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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
April 2011
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00313404
0584-2002, EPA-5 R01 AI056351-03, 82911601-1, RSPHGH-CLM-2005-EPANoV
No
Christine Moe, PhD, Emory University
Emory University
Johns Hopkins University
Principal Investigator: Christine Moe, PhD Emory University
Principal Investigator: George M Lyon III, MD, MMSc Emory University
Principal Investigator: Kellogg Schwab, PhD Johns Hopkins University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP