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

Vaxart0 sites54 target enrollmentApril 2011

ConditionsAvian Influenza Bird Flu

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Avian Influenza
Sponsor: Vaxart
Enrollment: 54
Primary Endpoint: Frequency or severity of vaccine related events as measured through reported AEs
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

September 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vaxart

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Frequency or severity of vaccine related events as measured through reported AEs

Time Frame: up to 1 year

Secondary Outcomes

Magnitude of humoral immune responses to avian influenza as measured by functional assays(up to 1 year)
Magnitude of cellular immune responses to avian influenza as measured by functional assays(up to 1 year)