Infectivity of Norovirus in Groundwater-Human Challenge Study

Conditions

Healthy

Keywords

Norovirus, Gastroenteritis, Clinical Trial, Stomach flu

Brief 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.

Scot Seitz, Juan S. León, Kellogg J. Schwab, G. Marshall Lyon, Melissa Dowd et al. (11 authors)

UNC Libraries2020-10-31

10.17615/z428-8a69

Changes in micronutrient and inflammation serum biomarker concentrations after a norovirus human challenge.

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.

2019-12-0128 citations

10.1093/ajcn/nqz201

Norovirus infectivity in humans and persistence in water.

Seitz SR, Leon JS, Schwab KJ, Lyon GM, Dowd M, McDaniels M, Abdulhafid G, Fernandez ML, Lindesmith LC, Baric RS, Moe CL.

2011-08-19205 citations

10.1128/aem.05806-11

Interventions

BIOLOGICALSafety tested norovirus inoculum

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

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Infection with norovirus	Throughout study

Countries

United States

Outcome results

None listed