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New Challenge Pool of Norwalk Virus Inoculum

NCT00138476 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2014-05-09

No results posted yet for this study

Summary

The main objective of this study is to see the number of volunteers that get sick from a Norwalk virus (NV) inoculation with typical symptoms of nausea, vomiting, and diarrhea. If this NV preparation is shown to cause Norwalk illness, then it can be used to test new vaccines in the future. Additionally, researchers hope to determine the lowest dose of NV inoculum that can be given to volunteers and cause illness. Study participants will include 57 healthy adults, ages 18-50. Participants will either be given the NV inoculum or placebo (water without virus). Participants will be hospitalized for a maximum of 7 days and a minimum of 4 days following the NV challenge. Study procedures include physical exam, blood testing, and collection of saliva, urine, and stool samples. Participants will be involved in study related procedures for up to 180 days.

Conditions

  • Gastroenteritis Norovirus

Interventions

DRUG

Placebo

120 mL of the sodium bicarbonate solution, followed by 82 mL of sterile water, United States Pharmacopeia (USP) without virus; followed by 500 mg of sodium bicarbonate aqueous solution taken 5 minutes after placebo inoculation.

BIOLOGICAL

Norwalk Virus

Prepared and packaged from liquid feces (DC544) by clarification, centrifugation, and serial dilutions; desired doses \[reverse transcription polymerase chain reaction (RT-PCR) Units\] 4800, 48, 4.8, 0.48.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2012-04-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00138476 on ClinicalTrials.gov