Clinical trial NCT00313404: Infectivity of Norovirus in Groundwater-Human Challenge Study
Official title: Assessment of Calicivirus Survival in Surface Water and Subsurface Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Norovirus
Gastroenteritis
Clinical Trial
Stomach flu
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2006-04-12
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Infection with norovirus
timeFrame: Throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University General Clinical Research Center
state: Georgia
Study officials:
affiliation: Emory University
name: Christine Moe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: George M Lyon III, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Kellogg Schwab, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.