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NCT01322503 · ClinicalTrials.gov registry record · Phase 1
Susceptibility of Human Volunteers With Different Histo-Blood With Different Histo-Blood Group Antigens to Norovirus
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01322503 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 40 participants.
The verdict
NCT01322503, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Objectives: To evaluate the role of human histo-blood group antigens in susceptibility to Norovirus infections. Description of Study Design: Healthy volunteers with different blood types and low antibody titers to the challenge strain will be challenged orally with a Norovirus in the CCCR inpatient facility. Subjects with resistant (non-secretors) or susceptible (secretors (of either A, B or O blood group)) to the challenge strain will be recruited. The challenge study will be conducted in two groups of twenty, each with approximately ten secretors and ten non-secretors. Three additional subjects per group will serve as alternates in the event that any of the study subjects are unavailable or become ineligible at the time of the inpatient study. Subjects will be monitored daily in the isolation facility for at least five days following this challenge for daily clinical and virological evaluations. Subjects will return to the investigational site for evaluation the day after discharge from the inpatient unit and about 30 days (28-35 days) post challenge. Study Endpoints: Norovirus infection as assessed by viral shedding, seroconversion and clinical illness assessed by the duration and severity of symptoms
Interventions
- BIOLOGICAL Norovirus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01322503
The ClinicalTrials.gov registry entry for NCT01322503 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Norovirus is the first listed.
NCT01322503 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01322503 about?
NCT01322503 is a clinical study titled "Susceptibility of Human Volunteers With Different Histo-Blood With Different Histo-Blood Group Antigens to Norovirus". Objectives: To evaluate the role of human histo-blood group antigens in susceptibility to Norovirus infections. Description of Study Design: Healthy volunteers with different blood types and low antibody titers to the challenge strain will be challenged orally with a Norovirus in the CCCR inpatient...
What is the current status of trial NCT01322503?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2010-10. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01322503?
The interventions under investigation include: Norovirus (BIOLOGICAL).
Who is sponsoring clinical trial NCT01322503?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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