Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Study Overview
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Brief Summary
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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
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Low and mid dose study was conducted under protocol number VXA02-001 High dose study was conducted under protocol number VXA02-003

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: VXA-A1.1 Oral Vaccine
* Biological: VXA Placebo Tablet


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: 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

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: Low Dose VXA-A1.1 Oral Vaccine<br>Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation. | Biological: VXA-A1.1 Oral Vaccine<br>* One or two doses of replication incompetent adenovirus oral tablet vaccine<br>* Other names: Ad-HA-dsRNA (VXA-A1.1);|
| Placebo Comparator: VXA Placebo Tablet<br>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. | Biological: VXA Placebo Tablet<br>* Off-white tablets similarly formulated to the active drug product tablets.<br>* Other names: Placebo Control;|
| Experimental: Medium Dose VXA-A1.1 Oral Vaccine<br>Two doses of replication incompetent adenovirus vaccine given in an oral tablet | Biological: VXA-A1.1 Oral Vaccine<br>* One or two doses of replication incompetent adenovirus oral tablet vaccine<br>* Other names: Ad-HA-dsRNA (VXA-A1.1);|
| Experimental: High Dose VXA-A1.1 Oral Vaccine<br>One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003. | Biological: VXA-A1.1 Oral Vaccine<br>* One or two doses of replication incompetent adenovirus oral tablet vaccine<br>* Other names: Ad-HA-dsRNA (VXA-A1.1);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events |  | One year following last vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude of humoral immune response to influenza as measured by functional assays |  | 28 Days and 180 Days post-vaccination | 
| Magnitude of cellular immune responses to influenza as measured by functional assays |  | 28 Days and 180 Days post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, H1N1, flu, seasonal