CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 135 enrolled
Drug / intervention
Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose +3 moredrug
Likely dose
Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dosefrom 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.

Search/NCT05626803
NCT05626803Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old.

Vaxart·interventional·Posted Nov 25, 2022·Updated Apr 15, 2025

In Brief

A Phase 2 clinical trial evaluating Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, and 2 other interventions for Norovirus Infections. Completed, enrolled 135 participants across 3 sites.

Detailed Summary

This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNorovirus Infections
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedNov 25, 2022
Enrollment StartJan 26, 2023
Primary CompletionOct 16, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.6 years ago

Interventions

Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dosedrug

The first 10 sentinel subjects will receive open label high dose of active vaccine. Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets; total dose is 2×10 to the power 11 IU/dose

Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dosedrug

50 subjects will receive high dose of active vaccine. Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets; total dose is 2×10 to the power 11 IU/dose

Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dosedrug

50 subjects will receive Bivalent GII.4/GI.1 medium dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 5×10 to the power 10 tablets; total dose is 1×10 to the power 11 IU/dose

Placebodrug

25 subjects will receive matching placebo