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NCT05212168 · ClinicalTrials.gov registry record · Phase 1
Norovirus Challenge Study
A Phase 1 study, sponsored by Vaxart.
- Completed
- Registry status
- Phase 1
- Development phase
- 165
- Enrollment target
NCT05212168 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 165 participants.
The verdict
NCT05212168, a Phase 1 study, has completed, sponsored by Vaxart.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 165 participants
- Enrollment target
Study Summary
This is a Phase 2b randomized, double-blind, placebo-controlled vaccination and challenge study to assess the protective efficacy of the Vaxart Norovirus vaccine (VXA-G1.1-NN). Healthy adults will be randomized in a 1:1 ratio to receive one oral dose of vaccine or placebo. * Arm 1: VXA-G1.1-NN oral vaccine tablets \[1x1011 IU±0.5 log\] * Arm 2: Placebo tablets similar in appearance and number to active vaccine tablets Approximately 28 days post-vaccination, subjects will be admitted to an isolation ward and challenged with the NV GI.1 Norwalk challenge strain. After challenge, subjects will be monitored for signs and symptoms of acute gastroenteritis (AGE) from Day 29 to discharge. At 4 days post challenge (Day 33) asymptomatic subjects will be discharged from the isolation ward and will be followed in a series of outpatient visits and telephone calls. Symptomatic subjects may be kept in the isolation ward for up to an additional 3 days.
Interventions
- OTHER Placebo Tablets
- BIOLOGICAL VXA-G1.1-NN
- BIOLOGICAL Norovirus GI.1 Norwalk Virus Inoculum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2021-12-27 |
| Est. Completion | 2023-10-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05212168
The ClinicalTrials.gov registry entry for NCT05212168 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vaxart, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Tablets is the first listed.
NCT05212168 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05212168 about?
NCT05212168 is a clinical study titled "Norovirus Challenge Study". This is a Phase 2b randomized, double-blind, placebo-controlled vaccination and challenge study to assess the protective efficacy of the Vaxart Norovirus vaccine (VXA-G1.1-NN). Healthy adults will be randomized in a 1:1 ratio to receive one oral dose of vaccine or placebo. * Arm 1: VXA-G1.1-NN oral...
What is the current status of trial NCT05212168?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 165 participants. The study started on 2021-12-27. Estimated completion is 2023-10-27.
What interventions are being tested in trial NCT05212168?
The interventions under investigation include: Placebo Tablets (OTHER), VXA-G1.1-NN (BIOLOGICAL), Norovirus GI.1 Norwalk Virus Inoculum (BIOLOGICAL).
Who is sponsoring clinical trial NCT05212168?
This trial is sponsored by Vaxart, which has 19 total clinical trials registered on ClinicalTrials.gov.
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