Clinical trial NCT01688297: Safety Study of an Oral Vaccine to Prevent Seasonal Influenza
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Influenza
H1N1
flu
seasonal
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2012-09-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: Low and mid dose study was conducted under protocol number VXA02-001

High dose study was conducted under protocol number VXA02-003

Eligibility criteria: 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

Primary outcomes:
measure: Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events
timeFrame: One year following last vaccination
Secondary outcomes:
measure: Magnitude of humoral immune response to influenza as measured by functional assays
timeFrame: 28 Days and 180 Days post-vaccination
measure: Magnitude of cellular immune responses to influenza as measured by functional assays
timeFrame: 28 Days and 180 Days post-vaccination
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT
state: California
Study officials:
affiliation: Vaxart, Inc.
name: David Liebowitz, MD, PhD
role: STUDY_DIRECTOR
affiliation: WCCT
name: Apinya Vutikullird, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liebowitz D, Lindbloom JD, Brandl JR, Garg SJ, Tucker SN. High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial. Lancet Infect Dis. 2015 Sep;15(9):1041-1048. doi: 10.1016/S1473-3099(15)00266-2.