Infectivity of Norovirus in Groundwater-Human Challenge Study - Full Text View

Sponsors and Collaborators:	Emory University Johns Hopkins University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00313404

Purpose

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.

Condition	Intervention
Healthy	Biological: Safety tested norovirus inoculum

MedlinePlus related topics: Drinking Water Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	Assessment of Calicivirus Survival in Surface Water and Subsurface Water

Further study details as provided by Emory University:

Primary Outcome Measures:

Infection with norovirus [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2010
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

This is a safety tested live infectious norovirus inoculum that has been placed in groundwater that meets EPA drinking water standards

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313404

Locations

United States, Georgia
Emory University General Clinical Research Center
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Johns Hopkins University

Investigators

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

More Information

Responsible Party:	Emory University ( Christine Moe )
Study ID Numbers:	RSPHGH-CLM-2005-EPANoV, EPA-5 R01 AI056351-03
Study First Received:	April 10, 2006
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00313404
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Norovirus
Gastroenteritis
Clinical Trial
Stomach flu

Study placed in the following topic categories:

Influenza, Human
Healthy
Gastroenteritis

ClinicalTrials.gov processed this record on January 16, 2009