Safety Study of an Oral Vaccine to Prevent Avian Influenza

Phase 1

Completed

• Conditions: Avian Influenza; Bird Flu
• Interventions: Biological: ND1.1; Biological: Placebo control

• Registration Number: NCT01335347
• Lead Sponsor: Vaxart

Brief Summary

The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-10
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-14
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Has had any other vaccines within the past 8 weeks.
• Has had prior H5 avian influenza investigational vaccine.
• Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
• History of autoimmune related disease.
• History of any confirmed or suspected immunodeficient or immunosuppressive condition (no congenital or acquired condition that impedes normal immune response, no concurrent immunosuppressive therapy).
• 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 or safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine.
• Use of proton pump inhibitors (Nexium, Prilosec) that substantially increases stomach pH.
• 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
Experimental Low Dose	ND1.1	Biological: One dose of a live replication incompetent adenovirus given in a capsule
Experimental Medium Dose	ND1.1	Biological: One or two doses of replication incompetent adenovirus given in a capsule Other: Placebo capsules of the same size and shape
Experimental High Dose	ND1.1	Biological: One dose of replication incompetent adenovirus in a capsule
Placebo Control	Placebo control	Capsules of the same size and shape as the experimental

Primary Outcome Measures

Name	Time	Method
Frequency or severity of vaccine related events as measured through reported AEs	up to 1 year

Secondary Outcome Measures

Name	Time	Method
Magnitude of humoral immune responses to avian influenza as measured by functional assays	up to 1 year
Magnitude of cellular immune responses to avian influenza as measured by functional assays	up to 1 year