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Completed

NCT Number: NCT01688297

Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

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).

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT

Cypress, California, 90630, United States

About this study

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

High dose study was conducted under protocol number VXA02-003

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VXA-A1.1 Oral Vaccine

Biological

One or two doses of replication incompetent adenovirus oral tablet vaccine

Other names: Ad-HA-dsRNA (VXA-A1.1)

VXA Placebo Tablet

Biological

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

Other names: Placebo Control

Primary outcomes

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

    Time frame: One year following last vaccination

Secondary outcomes

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

    Time frame: 28 Days and 180 Days post-vaccination

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

    Time frame: 28 Days and 180 Days post-vaccination

Sponsors and collaborators

Lead sponsor

Vaxart

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Sep 19, 2012
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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