Safety Study of an Oral Vaccine to Prevent Avian Influenza

Completed · Phase 1 · Has a placebo group

Conditions studied: Avian Influenza, Bird Flu

In brief

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.

Key facts

Study ID: NCT01335347
Run by: Vaxart
People needed: 54
Starts: 2011-04-01
Expected to finish: 2012-09-01
Last updated by the study team: 2013-01-03

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

In good health as established by medical history, physical examination and laboratory testing at the time of enrollment.

You may not qualify if…

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

Where it is running

Study site — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.