A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old
← catalyst calendarSponsored by Vaxart (industry) · VXRT — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Prevention
Enrollment
60actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-03 | actual | When the study began enrolling |
| Primary completion | 2026-04-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-14 | actual | The whole study's end, after follow-up |
| First posted | 2025-04-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Norovirus Infections
Interventions
- Biological: VXA-G1.1-NN
- Biological: VXA-G2.4-NS
- Biological: VXA G1.1 NN-T
- Biological: VXA G2.4 NS-T
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants Experiencing Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose
measured 7 days
Duration of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose
measured Approximately 1 year
Severity of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose
measured 7 days
Number of Participants Experiencing Unsolicited Adverse Events (AE) for 28 Days Following the Study Intervention Dose
measured 28 days
Number of Participants Experiencing Unsolicited New Onset of Chronic Illness (NOCI) for 28 Days Following the Study Intervention Dose
measured 28 days
Duration of Unsolicited AEs for 28 Days Following the Study Intervention Dose
measured Approximately 1 year
Duration of Unsolicited NOCIs for 28 Days Following the Study Intervention Dose
measured Approximately 1 year
Severity of Unsolicited AEs for 28 Days Following the Study Intervention Dose
measured 28 days
Severity of Unsolicited NOCIs for 28 Days Following the Study Intervention Dose
measured 28 days
Geometric Mean Titer (GMT) at Day 0 of Serum Functional Antibody Against GI.1 Measured by Norovirus Blocking Antibody Assay (NBAA)
measured Day 0
GMT at Day 28 of Serum Functional Antibody Against GI.1 Measured by NBAA
measured Day 28
GMT at Day 0 of Serum Functional Antibody Against GII.4 Measured by NBAA
measured Day 0
GMT at Day 28 of Serum Functional Antibody Against GII.4 Measured by NBAA
measured Day 28
Geometric Mean Fold Rise (GMFR) from Day 0 to Day 28 of Serum Functional Antibody Against GI.1 Measured by NBAA
measured From Day 0 to Day 28
GMFR from Day 0 to Day 28 of Serum Functional Antibody Against GII.4 Measured by NBAA
measured From Day 0 to Day 28
Permalink · VXRT's whole pipeline · Catalyst calendar · Every registered study · What changed