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Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers

NCT03125473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-05-30

No results posted yet for this study

Summary

A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1 VP1 and dsRNA adjuvant administered orally to healthy volunteers

Conditions

  • Norovirus Gastroenteritis

Interventions

BIOLOGICAL

VXA-G1.1-NN Oral Vaccine

The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high total doses.

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

  • Laura Sterling, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-07
Primary Completion
2017-07-01
Completion
2018-05-06
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 NCT03125473 on ClinicalTrials.gov