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Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults

NCT03121339 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-05-30

No results posted yet for this study

Summary

This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. The secondary objective is to evaluate delivery with fasting versus fed status.

Conditions

  • Seasonal Influenza Preventative Vaccine Pharmacodynamics

Interventions

BIOLOGICAL

VXA-A1.1 H1 Tablet Vaccine (small)

Tableted oral H1 vaccine (\~140 mg tablet)

BIOLOGICAL

VXA-A1.1 H1 Tablet Vaccine (large)

Tableted oral H1 vaccine (\~275 mg tablet)

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2017-05-05
Completion
2018-04-03
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 NCT03121339 on ClinicalTrials.gov