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

This study has been completed.
Sponsor:
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Christine Moe, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00674336
First received: May 6, 2008
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 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.


Condition Intervention
Healthy
Procedure: High Hydrostatic Pressure Processing

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach

Further study details as provided by Emory University:

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

Enrollment: 51
Study Start Date: September 2007
Study Completion Date: March 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shellfish with Norovirus
We dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus
Procedure: High Hydrostatic Pressure Processing
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.
Other Name: HPP

  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
  • 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
  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: NCT00674336

Locations
United States, Georgia
Emory University General Clinical Research Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Virginia Polytechnic Institute and State University
Investigators
Principal Investigator: Christine Moe, PhD Emory University
Principal Investigator: George M Lyon III, MD, MMSc Emory University
  More Information

Publications:
Responsible Party: Christine Moe, PhD, Gangarosa Professor, Emory University
ClinicalTrials.gov Identifier: NCT00674336     History of Changes
Other Study ID Numbers: 0551-2006, RSPHGH-CLM-2007-NoVSHELLFISH
Study First Received: May 6, 2008
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Norovirus
Gastroenteritis
Clinical Trial
Stomach flu
Oysters
Shellfish
high hydrostatic pressures

ClinicalTrials.gov processed this record on September 30, 2014