Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: VXA Placebo Tablet; Biological: VXA-A1.1 Oral Vaccine

• 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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VXA Placebo Tablet	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.
High Dose VXA-A1.1 Oral Vaccine	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.
Medium Dose VXA-A1.1 Oral Vaccine	VXA-A1.1 Oral Vaccine	Two doses of replication incompetent adenovirus vaccine given in an oral tablet
Low Dose VXA-A1.1 Oral Vaccine	VXA-A1.1 Oral Vaccine	Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.

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 cellular immune responses to influenza as measured by functional assays	28 Days and 180 Days post-vaccination
Magnitude of humoral immune response to influenza as measured by functional assays	28 Days and 180 Days post-vaccination

Trial Locations

Locations (1)

WCCT; 🇺🇸 Cypress, California, United States