Safety Study of an Oral Vaccine to Prevent Avian Influenza (H5N1)

January 2, 2013 updated by: Vaxart

A Dose Escalation Phase 1 Safety and Immunogenicity Study of an Oral Viral Vector Vaccine Encoding Avian Influenza H5N1 Hemagglutinin Protein and dsRNA Adjuvant in Healthy Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Low Dose
Biological: One dose of a live replication incompetent adenovirus given in a capsule
Biological: ND1.1
adenovirus with the dsRNA adjuvant, dried and put into capsules
Other Names:
  • Ad-HA-dsRNA
Experimental: 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
Biological: ND1.1
adenovirus with the dsRNA adjuvant, dried and put into capsules
Other Names:
  • Ad-HA-dsRNA
Experimental: Experimental High Dose
Biological: One dose of replication incompetent adenovirus in a capsule
Biological: ND1.1
adenovirus with the dsRNA adjuvant, dried and put into capsules
Other Names:
  • Ad-HA-dsRNA
Placebo Comparator: Placebo Control
Capsules of the same size and shape as the experimental
Biological: Placebo control
Capsules of the same size and shape as experimental groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency or severity of vaccine related events as measured through reported AEs
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Magnitude of humoral immune responses to avian influenza as measured by functional assays
Time Frame: up to 1 year
up to 1 year
Magnitude of cellular immune responses to avian influenza as measured by functional assays
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vaxart

Investigators

  • Study Director: Sean N Tucker, PhD, Vaxart
  • Principal Investigator: Martin Kabongo, MD, PhD, Accelovance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 10, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VXA01-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Avian Influenza

Clinical Trials on ND1.1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe