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Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine

NCT02868073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-05-31

No results posted yet for this study

Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of 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 (high dose) Oral Vaccine Tablet

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

OTHER

VXA Placebo Tablets

The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.

BIOLOGICAL

VXA-G1.1-NN (low dose) Oral Vaccine Tablet

The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose.

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

  • Laura Sterling, MD, PhD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-07-29
Primary Completion
2016-10-05
Completion
2017-10-01

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 NCT02868073 on ClinicalTrials.gov