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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 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05213728
The ClinicalTrials.gov registry entry for NCT05213728 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 1 intervention - of which VXA-G1.1-NN is the first listed.
NCT05213728 reports 0 study locations.
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.
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