Safety Study of an Oral Vaccine to Prevent Avian Influenza

Study Overview
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Brief Summary
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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.

Official Title
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A Dose Escalation Phase 1 Safety and Immunogenicity Study of an Oral Viral Vector Vaccine Encoding Avian Influenza H5N1 Hemagglutinin Protein and dsRNA Adjuvant in Healthy Adults

Conditions
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Avian Influenza, Bird Flu

Intervention / Treatment
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* Biological: ND1.1
* Biological: Placebo control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Low Dose<br>Biological: One dose of a live replication incompetent adenovirus given in a capsule | Biological: ND1.1<br>* adenovirus with the dsRNA adjuvant, dried and put into capsules<br>* Other names: Ad-HA-dsRNA;|
| Experimental: Experimental Medium Dose<br>Biological: One or two doses of replication incompetent adenovirus given in a capsule Other: Placebo capsules of the same size and shape | Biological: ND1.1<br>* adenovirus with the dsRNA adjuvant, dried and put into capsules<br>* Other names: Ad-HA-dsRNA;|
| Experimental: Experimental High Dose<br>Biological: One dose of replication incompetent adenovirus in a capsule | Biological: ND1.1<br>* adenovirus with the dsRNA adjuvant, dried and put into capsules<br>* Other names: Ad-HA-dsRNA;|
| Placebo Comparator: Placebo Control<br>Capsules of the same size and shape as the experimental | Biological: Placebo control<br>* Capsules of the same size and shape as experimental groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency or severity of vaccine related events as measured through reported AEs |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, pandemic, avian influenza, H5N1, flu