Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Completed · Phase 1 · Has a placebo group

Conditions studied: Influenza

In brief

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).

Key facts

Study ID

NCT01688297

Run by

Vaxart

People needed

61

Starts

2012-09-01

Expected to finish

2015-04-01

Last updated by the study team

2017-05-12

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• WCCT — Cypress, California, United States

Full record on ClinicalTrials.gov

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