Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-04-30

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).

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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

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low Dose VXA-A1.1 Oral Vaccine

Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.

Group Type EXPERIMENTAL

VXA-A1.1 Oral Vaccine

Intervention Type BIOLOGICAL

One or two doses of replication incompetent adenovirus oral tablet vaccine

VXA Placebo Tablet

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.

Group Type PLACEBO_COMPARATOR

VXA Placebo Tablet

Intervention Type BIOLOGICAL

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

Medium Dose VXA-A1.1 Oral Vaccine

Two doses of replication incompetent adenovirus vaccine given in an oral tablet

Group Type EXPERIMENTAL

VXA-A1.1 Oral Vaccine

Intervention Type BIOLOGICAL

One or two doses of replication incompetent adenovirus oral tablet vaccine

High Dose VXA-A1.1 Oral Vaccine

One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003.

Group Type EXPERIMENTAL

VXA-A1.1 Oral Vaccine

Intervention Type BIOLOGICAL

One or two doses of replication incompetent adenovirus oral tablet vaccine

Interventions

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VXA-A1.1 Oral Vaccine

One or two doses of replication incompetent adenovirus oral tablet vaccine

Intervention Type BIOLOGICAL

VXA Placebo Tablet

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Ad-HA-dsRNA (VXA-A1.1) Placebo Control

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes