Infectivity of Norovirus in Groundwater-Human Challenge Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00313404|
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : November 19, 2013
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 or disease||Intervention/treatment||Phase|
|Healthy||Biological: Safety tested norovirus inoculum||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Assessment of Calicivirus Survival in Surface Water and Subsurface Water|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||April 2011|
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
- Infection with norovirus [ Time Frame: Throughout study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|