Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Randomized Phase 1 Double-Blinded Placebo Controlled Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Seasonal Influenza A Vaccine and dsRNA Adjuvant Administered Orally to Healthy Volunteers

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).

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: VXA-A1.1 Oral Vaccine; Biological: VXA Placebo Tablet

Detailed Description

Low and mid dose study was conducted under protocol number VXA02-001

High dose study was conducted under protocol number VXA02-003

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low Dose VXA-A1.1 Oral Vaccine; Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.	Biological: VXA-A1.1 Oral Vaccine; One or two doses of replication incompetent adenovirus oral tablet vaccine; Other Names: Ad-HA-dsRNA (VXA-A1.1)
PLACEBO_COMPARATOR: VXA Placebo Tablet; 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; Off-white tablets similarly formulated to the active drug product tablets.; Other Names: Placebo Control
EXPERIMENTAL: Medium Dose VXA-A1.1 Oral Vaccine; Two doses of replication incompetent adenovirus vaccine given in an oral tablet	Biological: VXA-A1.1 Oral Vaccine; One or two doses of replication incompetent adenovirus oral tablet vaccine; Other Names: Ad-HA-dsRNA (VXA-A1.1)
EXPERIMENTAL: High Dose VXA-A1.1 Oral Vaccine; 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; One or two doses of replication incompetent adenovirus oral tablet vaccine; Other Names: Ad-HA-dsRNA (VXA-A1.1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events	One year following last vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Vaxart
• Investigators: Principal Investigator: Apinya Vutikullird, DO, WCCT

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: September 14, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (ESTIMATE): September 19, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Influenza; flu; H1N1; seasonal
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: VXA02-001 & VXA02-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No