Infectivity of Norovirus in Groundwater-Human Challenge Study

NCT00313404 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-11-19

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Christine Moe, PhD · Emory University

  • George M Lyon III, MD, MMSc · Emory University

  • Kellogg Schwab, PhD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-01-31
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00313404 on ClinicalTrials.gov