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A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

NCT06944717 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-29

No results posted yet for this study

Summary

The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants.

Conditions

  • Norovirus Infections

Interventions

BIOLOGICAL

VXA-G1.1-NN

Legacy vaccine, administered orally.

BIOLOGICAL

VXA-G2.4-NS

Legacy vaccine, administered orally.

BIOLOGICAL

VXA G1.1 NN-T

Next generation vaccine, administered orally.

BIOLOGICAL

VXA G2.4 NS-T

Next generation vaccine, administered orally.

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2026-05-01
Completion
2026-05-01
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 NCT06944717 on ClinicalTrials.gov