Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study

Study Overview
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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 the effectiveness of high hydrostatic pressures processing (HPP) treatment on norovirus infected shellfish. Norwalk virus can survive in shellfish and still be able to cause sickness. HPP inactivates microorganisms living both on the surface and on the interior of the food. The goal of the study is to determine whether HPP treatment on oysters spiked with norovirus will reduce infection rates in people consuming raw infected oysters.

Official Title
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Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach

Conditions
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Healthy

Intervention / Treatment
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* Procedure: High Hydrostatic Pressure Processing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal healthy volunteer Age must be between 18 and 50 years of age Exclusion Criteria: Have a job in which you handle food Are a health care worker with direct patient contact Work in a child care, elderly care center or if you live with young children or anyone who has a weak immune system Are not willing or able to wash your hands every time after you go to the bathroom, or before and after you prepare or handle food throughout the whole study Are anemic Are not willing to give us permission to store and use your data and samples

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shellfish with Norovirus<br>We dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus | Procedure: High Hydrostatic Pressure Processing<br>* High Hydrostatic Pressure Processing is a technology, used in the food service industry, where foods are subjected to high pressure. These high pressures kill many pathogens without affecting the quality of the food.<br>* Other names: HPP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection with norovirus |  | Throughout participation in study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Norovirus, Gastroenteritis, Clinical Trial, Stomach flu, Oysters, Shellfish, high hydrostatic pressures