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Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine

NCT04854746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-02-13

No results posted yet for this study

Summary

A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)

Conditions

  • Norovirus Infections

Interventions

BIOLOGICAL

VXA-GI.1.NN

GI.1 oral vaccine tablet

BIOLOGICAL

Placebo Tablet

Tablets matching in number and appearance to active vaccine tablets

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

  • David Liebowitz, MD, PhD · Vaxart, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2022-01-04
Completion
2022-01-04
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 NCT04854746 on ClinicalTrials.gov