Safety Study of an Oral Vaccine to Prevent Avian Influenza

Avian Influenza Clinical Trial

— H5N1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335347
• Other study ID #: VXA01-001
• Status: Completed
• Phase: Phase 1
• First received: April 10, 2011
• Last updated: January 2, 2013
• Start date: April 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avian Influenza
• Bird Flu
• Influenza, Human

Intervention

Biological:
• ND1.1
adenovirus with the dsRNA adjuvant, dried and put into capsules
• Placebo control
Capsules of the same size and shape as experimental groups

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vaxart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency or severity of vaccine related events as measured through reported AEs		up to 1 year	Yes
Secondary	Magnitude of humoral immune responses to avian influenza as measured by functional assays		up to 1 year	No
Secondary	Magnitude of cellular immune responses to avian influenza as measured by functional assays		up to 1 year	No