Safety Study of an Oral Vaccine to Prevent Seasonal Influenza
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 5/13/2017 |
| Start Date: | September 2012 |
| End Date: | April 2015 |
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
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).
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).
Low and mid dose study was conducted under protocol number VXA02-001
High dose study was conducted under protocol number VXA02-003
High dose study was conducted under protocol number VXA02-003
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
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