Trial | NCT01335347  Report issue

Title

Safety Study of an Oral Vaccine to Prevent Avian Influenza
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nd1.1 ...

  • Study Participants

    54
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 Started
Apr 30
2011
Primary Completion
Aug 31
2012
Study Completion
Sep 30
2012
Last Update
Jan 03
2013
Estimate

Biological ND1.1

adenovirus with the dsRNA adjuvant, dried and put into capsules

  • Other names: Ad-HA-dsRNA

Biological Placebo control

Capsules of the same size and shape as experimental groups

Experimental Low Dose Experimental

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

Experimental Medium Dose Experimental

Biological: One or two doses of replication incompetent adenovirus given in a capsule Other: Placebo capsules of the same size and shape

Experimental High Dose Experimental

Biological: One dose of replication incompetent adenovirus in a capsule

Placebo Control Placebo Comparator

Capsules of the same size and shape as the experimental

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
No Results Posted