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NCT05213728 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers
A Phase 1 study, sponsored by Vaxart.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT05213728: Completed Phase 1 study, sponsored by Vaxart.
NCT05213728 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05213728, a Phase 1 study, has completed, sponsored by Vaxart.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.
Primary Outcome
To assess the safety and tolerability of an oral tableted vaccine by collection of solicited symptoms of vaccine reactogenicity recorded daily using a subject diary card for 1 week post initial vaccination at Day 1.
Interventions
- BIOLOGICAL VXA-G1.1-NN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2022-02-24 |
| Phase | Phase 1 |
What the finished NCT05213728 record still lists
NCT05213728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which VXA-G1.1-NN is the first listed.
NCT05213728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05213728 about?
NCT05213728 is a clinical study titled "A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers". Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at D...
What is the current status of trial NCT05213728?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-01-24. Estimated completion is 2022-02-24.
What interventions are being tested in trial NCT05213728?
The interventions under investigation include: VXA-G1.1-NN (BIOLOGICAL).
Who is sponsoring clinical trial NCT05213728?
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 NCT05213728's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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