Safety Study of an Oral Vaccine to Prevent Avian 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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.

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Detailed Description

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Conditions

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Avian Influenza Bird Flu

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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Experimental Low Dose

Biological: One dose of a live replication incompetent adenovirus given in a capsule

Group Type EXPERIMENTAL

ND1.1

Intervention Type BIOLOGICAL

adenovirus with the dsRNA adjuvant, dried and put into capsules

Experimental Medium Dose

Biological: One or two doses of replication incompetent adenovirus given in a capsule

Other: Placebo capsules of the same size and shape

Group Type EXPERIMENTAL

ND1.1

Intervention Type BIOLOGICAL

adenovirus with the dsRNA adjuvant, dried and put into capsules

Experimental High Dose

Biological: One dose of replication incompetent adenovirus in a capsule

Group Type EXPERIMENTAL

ND1.1

Intervention Type BIOLOGICAL

adenovirus with the dsRNA adjuvant, dried and put into capsules

Placebo Control

Capsules of the same size and shape as the experimental

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type BIOLOGICAL

Capsules of the same size and shape as experimental groups

Interventions

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ND1.1

adenovirus with the dsRNA adjuvant, dried and put into capsules

Intervention Type BIOLOGICAL

Placebo control

Capsules of the same size and shape as experimental groups

Intervention Type BIOLOGICAL

Other Intervention Names

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Ad-HA-dsRNA

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

* Has had any other vaccines within the past 8 weeks.
* Has had prior H5 avian influenza investigational vaccine.
* Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
* History of autoimmune related disease.
* History of any confirmed or suspected immunodeficient or immunosuppressive condition (no congenital or acquired condition that impedes normal immune response, no concurrent immunosuppressive therapy).
* 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 or safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine.
* Use of proton pump inhibitors (Nexium, Prilosec) that substantially increases stomach pH.
* 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