Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Vaxart61 enrolled

Overview

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).

Low and mid dose study was conducted under protocol number VXA02-001 High dose study was conducted under protocol number VXA02-003

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Influenza

Interventions

VXA-A1.1 Oral VaccineBIOLOGICAL

One or two doses of replication incompetent adenovirus oral tablet vaccine

VXA Placebo TabletBIOLOGICAL

Off-white tablets similarly formulated to the active drug product tablets.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

WCCT

Cypress, California, United States

Outcomes

Primary Outcomes

Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events

Time frame: One year following last vaccination

Secondary Outcomes

Magnitude of humoral immune response to influenza as measured by functional assays

Time frame: 28 Days and 180 Days post-vaccination

Magnitude of cellular immune responses to influenza as measured by functional assays

Time frame: 28 Days and 180 Days post-vaccination

Data from ClinicalTrials.gov

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