NCT01688297

Brief Summary

The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

September 14, 2012

Last Update Submit

May 11, 2017

Conditions

Influenza

Keywords

InfluenzaH1N1fluseasonal

Outcome Measures

Primary Outcomes (1)

  • Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events

    One year following last vaccination

Secondary Outcomes (2)

  • Magnitude of humoral immune response to influenza as measured by functional assays

    28 Days and 180 Days post-vaccination

  • Magnitude of cellular immune responses to influenza as measured by functional assays

    28 Days and 180 Days post-vaccination

Study Arms (4)

Low Dose VXA-A1.1 Oral Vaccine

EXPERIMENTAL

Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.

Biological: VXA-A1.1 Oral Vaccine

VXA Placebo Tablet

PLACEBO COMPARATOR

Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design.

Biological: VXA Placebo Tablet

Medium Dose VXA-A1.1 Oral Vaccine

EXPERIMENTAL

Two doses of replication incompetent adenovirus vaccine given in an oral tablet

Biological: VXA-A1.1 Oral Vaccine

High Dose VXA-A1.1 Oral Vaccine

EXPERIMENTAL

One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003.

Biological: VXA-A1.1 Oral Vaccine

Interventions

VXA-A1.1 Oral VaccineBIOLOGICAL

One or two doses of replication incompetent adenovirus oral tablet vaccine

Also known as: Ad-HA-dsRNA (VXA-A1.1)
High Dose VXA-A1.1 Oral VaccineLow Dose VXA-A1.1 Oral VaccineMedium Dose VXA-A1.1 Oral Vaccine
VXA Placebo TabletBIOLOGICAL

Off-white tablets similarly formulated to the active drug product tablets.

Also known as: Placebo Control
VXA Placebo Tablet

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.

You may not qualify if:

  • Positive for H1 influenza by HAI.
  • Has had an influenza vaccine in the past 2 years.
  • Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
  • History of any confirmed or suspected immunodeficient or immunosuppressive condition
  • Positive serology for HIV, HCV, or HBV
  • Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
  • History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution of the vaccine targeting the mucosa of the small intestine
  • Use of proton pump inhibitors(Nexium, Prilosec).
  • Stool sample with occult blood at baseline exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WCCT

Cypress, California, 90630, United States

Location

Related Publications (1)

  • Liebowitz D, Lindbloom JD, Brandl JR, Garg SJ, Tucker SN. High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial. Lancet Infect Dis. 2015 Sep;15(9):1041-1048. doi: 10.1016/S1473-3099(15)00266-2.

    PMID: 26333337RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • David Liebowitz, MD, PhD

    Vaxart, Inc.

    STUDY DIRECTOR

  • Apinya Vutikullird, DO

    WCCT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2012

First Posted

September 19, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2014

Study Completion

April 1, 2015

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)