Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Phase 1

Completed

• Conditions: Influenza

• Registration Number: NCT01688297
• Lead Sponsor: Vaxart

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).

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-19
• Primary Completion: 2014-05
• Study Completion: 2015-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

WCCT; 🇺🇸 Cypress, California, United States