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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: Completed Phase 1 study, sponsored by Vaxart.
NCT05212168 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 165 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (175% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
NVG is a composite endpoint defined as meeting both the definition of AGE and NV. AGE was defined as meeting any one of 3 criteria (diarrhea, vomiting, or diarrhea and vomiting) in any 24-hr rolling period. The individual criteria for diarrhea, vomiting, or diarrhea and vomiting were as follows: 1\. Diarrhea: i. ≥ 3 loose or liquid stools in any 24-hr rolling period, or ii. 400 g of loose or liquid stools in any 24-hr rolling period 2. Vomiting: ≥ 2 vomiting episodes in any 24-hr rolling perio
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 |
What the finished NCT05212168 record still lists
NCT05212168 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (175% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo Tablets is the first listed.
NCT05212168 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05212168's enrollment target sits among peer trials
165 332nd of 2000 higher than 1,666 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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