Safety Study of an Oral Vaccine to Prevent Avian Influenza (H5N1)

Vaxart

Status and phase: Completed; Phase 1

Conditions: Bird Flu; Avian Influenza

Treatments: Biological: ND1.1; Biological: Placebo control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01335347

VXA01-001

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In good health as established by medical history, physical examination and laboratory testing at the time of enrollment.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 4 patient groups, including a placebo group

Experimental Low Dose

Experimental group

Description:

Biological: One dose of a live replication incompetent adenovirus given in a capsule

Treatment:

Biological: ND1.1

Experimental Medium Dose

Experimental group

Description:

Biological: One or two doses of replication incompetent adenovirus given in a capsule Other: Placebo capsules of the same size and shape

Treatment:

Biological: ND1.1

Experimental High Dose

Experimental group

Description:

Biological: One dose of replication incompetent adenovirus in a capsule

Treatment:

Biological: ND1.1

Placebo Control

Placebo Comparator group

Description:

Capsules of the same size and shape as the experimental

Treatment:

Biological: Placebo control