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A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers

NCT05213728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-06-21

No results posted yet for this study

Summary

Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.

Conditions

  • Norovirus Infections

Interventions

BIOLOGICAL

VXA-G1.1-NN

Norovirus GI.1 Norwalk VP1 Vaccine (VXA-G1.1-NN) E1/E3-Deleted Replication-Defective Recombinant Adenovirus 5 with Adjuvant Oral Tablet Vaccine.

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

  • James Cummings, MD · Vaxart, Inc.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2022-02-01
Completion
2022-02-24
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 NCT05213728 on ClinicalTrials.gov