NCT01688297

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Vaxart · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	VXA-A1.1 Oral Vaccine	One or two doses of replication incompetent adenovirus oral tablet vaccine
BIOLOGICAL	VXA Placebo Tablet	Off-white tablets similarly formulated to the active drug product tablets.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-05-01
• Completion: 2015-04-01
• First posted: 2012-09-19
• Last updated: 2017-05-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study