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

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ClinicalTrials.gov Identifier: NCT00674336
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):

May 6, 2008
May 7, 2008
November 19, 2013
September 2007
October 2009   (Final data collection date for primary outcome measure)
Infection with norovirus [ Time Frame: Throughout participation in study ]
Same as current
Complete list of historical versions of study NCT00674336 on ClinicalTrials.gov Archive Site
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Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study
Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach

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.

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Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Experimental: Shellfish with Norovirus
We dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus
Intervention: Procedure: High Hydrostatic Pressure Processing
Leon JS, Kingsley DH, Montes JS, Richards GP, Lyon GM, Abdulhafid GM, Seitz SR, Fernandez ML, Teunis PF, Flick GJ, Moe CL. Randomized, double-blinded clinical trial for human norovirus inactivation in oysters by high hydrostatic pressure processing. Appl Environ Microbiol. 2011 Aug;77(15):5476-82. doi: 10.1128/AEM.02801-10. Epub 2011 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2010
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
RSPHGH-CLM-2007-NoVSHELLFISH ( Other Identifier: Other )
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Christine Moe, PhD, Emory University
Emory University
Virginia Polytechnic Institute and State University
Principal Investigator: Christine Moe, PhD Emory University
Principal Investigator: George M Lyon III, MD, MMSc Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP