At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
VXA-G1.1-NNbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Open-label, Boost-optimization Study of an Adenoviral- Vector Based Oral Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 Administered Orally to Healthy Adult Volunteers
In Brief
A Phase 2 clinical trial evaluating VXA-G1.1-NN for Norovirus Infections. Completed, enrolled 30 participants across 1 site.
Detailed Summary
To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55, inclusive
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNorovirus Infections
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartApr 2021
First PostedMay 2021
Primary CompletionOct 2021
Study CompletionFeb 2022
TodayJul 2026
First PostedMay 6, 2021
Enrollment StartApr 30, 2021
Primary CompletionOct 30, 2021
Study CompletionFeb 16, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.2 years ago
Interventions
VXA-G1.1-NNbiological
Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant