Infectivity of Norovirus in Groundwater-Human Challenge Study
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Assessment of Calicivirus Survival in Surface Water and Subsurface Water|
- Infection with norovirus [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Study Completion Date:||April 2011|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313404
|United States, Georgia|
|Emory University General Clinical Research Center|
|Atlanta, Georgia, United States, 30322|
|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|