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
  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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Infection with norovirus [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2006
Study Completion Date: April 2011
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Christine Moe, PhD, Gangarosa Professor, Emory University
ClinicalTrials.gov Identifier: NCT00313404     History of Changes
Other Study ID Numbers: 0584-2002, EPA-5 R01 AI056351-03, 82911601-1, RSPHGH-CLM-2005-EPANoV
Study First Received: April 10, 2006
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Norovirus
Gastroenteritis
Clinical Trial
Stomach flu

ClinicalTrials.gov processed this record on October 19, 2014