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Infectivity of Norovirus in Groundwater-Human Challenge Study

NCT ID: NCT00313404

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Norovirus Gastroenteritis Clinical Trial Stomach flu

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Safety tested norovirus inoculum

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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Norwalk virus in groundwater

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Christine Moe, PhD

Gangarosa Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Moe, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

George M Lyon III, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Kellogg Schwab, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Emory University General Clinical Research Center

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Seitz SR, Leon JS, Schwab KJ, Lyon GM, Dowd M, McDaniels M, Abdulhafid G, Fernandez ML, Lindesmith LC, Baric RS, Moe CL. Norovirus infectivity in humans and persistence in water. Appl Environ Microbiol. 2011 Oct;77(19):6884-8. doi: 10.1128/AEM.05806-11. Epub 2011 Aug 19.

Reference Type RESULT
PMID: 21856841 (View on PubMed)

Williams AM, Ladva CN, Leon JS, Lopman BA, Tangpricha V, Whitehead RD, Armitage AE, Wray K, Morovat A, Pasricha SR, Thurnham D, Tanumihardjo SA, Shahab-Ferdows S, Allen L, Flores-Ayala RC, Suchdev PS. Changes in micronutrient and inflammation serum biomarker concentrations after a norovirus human challenge. Am J Clin Nutr. 2019 Dec 1;110(6):1456-1464. doi: 10.1093/ajcn/nqz201.

Reference Type DERIVED
PMID: 31504095 (View on PubMed)

Other Identifiers

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EPA-5 R01 AI056351-03

Identifier Type: OTHER

Identifier Source: secondary_id

82911601-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RSPHGH-CLM-2005-EPANoV

Identifier Type: OTHER

Identifier Source: secondary_id

0584-2002

Identifier Type: -

Identifier Source: org_study_id