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NCT04174560 · ClinicalTrials.gov registry record · Phase 1
Phase I Norovirus Challenge Model
A Phase 1 study of Gastroenteritis Norovirus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04174560 is a Phase 1 study of Gastroenteritis Norovirus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04174560, a Phase 1 study of Gastroenteritis Norovirus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to 48 healthy non-pregnant adults, 18-49 years of age, negative for COVID-19 by antigen testing at the time of norovirus challenge. Subjects will be admitted to the Vaccine Research Center inpatient facility and challenged with a dose of human norovirus GII.4 challenge strain. The challenge study will be conducted in 3 cohorts of approximately 16 subjects each, 15 subjects will have a functional FUT-2 gene (secretor positive) and 1 subject will have a non-functional FUT-2 gene (non-secretor). Subjects in Cohort 1 will receive 3.5x10\^3 copies of norovirus, in Cohort 2 will receive 3.5x10\^4 copies of norovirus and in Cohort 3 will receive 3.5x10\^5 copies of norovirus. Based on the illness rate of subjects meeting the primary outcome measure in secretor - positive subjects of the initial cohort, the decision will be made with regards to dosing of the second and the third cohorts. Study duration is approximately 12-18 months with subject participation duration of 6-8 months. The primary objective of this study is to determine the optimal challenge dose of Norovirus GII.4 CIN-3 Batch No.: 01-16C3 to achieve illness in \> / = 50% of subjects (illness is defined as norovirus infection determined by positive Polymerase Chain Reaction (PCR) and either: a) \> / = 3 loose or liquid stools, in a 24-hour period, b) \> / = 300 gm of loose or liquid stool in a 24-hour period or c) and/or any episode of vomiting), during the inpatient period.
Conditions Studied
Interventions
- BIOLOGICAL Norovirus GII.4 Challenge Pool
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center Vaccine Research Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2024-01-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04174560
The ClinicalTrials.gov registry entry for NCT04174560 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gastroenteritis Norovirus appearing as the primary indexed condition, and to 1 intervention - of which Norovirus GII.4 Challenge Pool is the first listed.
NCT04174560 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT04174560 about?
NCT04174560 is a clinical study titled "Phase I Norovirus Challenge Model". This is a safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to 48 healthy non-pregnant adults, 18-49 years of age, negative for COVID-19 by antigen testing at the time of norovirus challenge. Subjects will be admitted to the Vaccine Research Center inpatient f...
What is the current status of trial NCT04174560?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-03-28. Estimated completion is 2024-01-08.
What conditions does trial NCT04174560 study?
This clinical trial studies the following conditions: Gastroenteritis Norovirus.
What interventions are being tested in trial NCT04174560?
The interventions under investigation include: Norovirus GII.4 Challenge Pool (BIOLOGICAL).
Who is sponsoring clinical trial NCT04174560?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04174560 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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