CompletedPhase 1

New Challenge Pool of Norwalk Virus Inoculum

United States57 participantsStarted 2004-08

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must be 18 to 50 years of age and in good health as determined by medical history and physical examination. * Subjects must sign informed consent prior to study initiation. * All screening clinical laboratory test results within the protocol-defined normal range. Subjects with a history of positive Hepatitis A antibody or vaccination and normal liver transaminases (serum) may be accepted. * If the subject is a woman, a negative serum pregnancy test within 3 days of inoculation and negative urine or blood pregnancy test on day of inoculation. * Subjects must be able to demonstrate a sufficient understanding of the study protocol and the ability to follow all required study procedures, including measures to prevent Norwalk Virus (NV) contamination of the environment and spread of NV infection and illness to the community. The prospective subjects must pass (\> 75 percent correct responses, or 21 of 27 questions answered correctly) a written examination before enrollment. The exam will contain 27 multiple choice or true/false questions on all aspects of the study protocol. Subjects will be re-instructed about any question they may have answered incorrectly. * Subjects must be available to return for follow-up visits following discharge from the General Clinical Research Center (GCRC) and deliver specimens to the investigator promptly. * Agree to storage of unused, identifiable clinical specimens for an indefinite period at Baylor College of Medici…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine the clinical attack rate for viral gastroenteritis induced by Norwalk Virus (NV) Lot 42399.

Timeframe: Up to 7 days or until clinical symptoms of diarrhea and vomiting have resolved.

Safety and acute toxicity of a new Norwalk virus challenge pool (Lot 42399) through clinical and laboratory monitoring of subjects.

Timeframe: Screening Days 30, 90, and 180

Determine the human infectious dose 50 percent of NV Lot 42399 based on viral shedding as measured by reverse transcription polymerase chain reaction (RT-PCR), by antigen shedding or by NV seroresponse by enzyme-linked immunosorbent assay (ELISA).

Timeframe: Screening, Days 2, 3, 4, 5, 6, 7, 14, 30, and 180.

Trial details

NCT IDNCT00138476

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2012-04

View on ClinicalTrials.gov More Gastroenteritis Norovirus trials