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Norovirus Challenge Study

NCT05212168 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-11-05

Study results available
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Summary

This is a Phase 2b randomized, double-blind, placebo-controlled vaccination and challenge study to assess the protective efficacy of the Vaxart Norovirus vaccine (VXA-G1.1-NN). Healthy adults will be randomized in a 1:1 ratio to receive one oral dose of vaccine or placebo.

* Arm 1: VXA-G1.1-NN oral vaccine tablets \[1x1011 IU±0.5 log\]
* Arm 2: Placebo tablets similar in appearance and number to active vaccine tablets

Approximately 28 days post-vaccination, subjects will be admitted to an isolation ward and challenged with the NV GI.1 Norwalk challenge strain. After challenge, subjects will be monitored for signs and symptoms of acute gastroenteritis (AGE) from Day 29 to discharge. At 4 days post challenge (Day 33) asymptomatic subjects will be discharged from the isolation ward and will be followed in a series of outpatient visits and telephone calls. Symptomatic subjects may be kept in the isolation ward for up to an additional 3 days.

Conditions

  • Norovirus Infections

Interventions

BIOLOGICAL

VXA-G1.1-NN

Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant

OTHER

Placebo Tablets

Oral tablets similar in appearance and number to active vaccine tablets

BIOLOGICAL

Norovirus GI.1 Norwalk Virus Inoculum

Norwalk Virus Inoculum Lot 01-09NV

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

  • James Cummings, MD · Vaxart, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-27
Primary Completion
2023-04-13
Completion
2023-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05212168 on ClinicalTrials.gov