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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01335347

Acronym

H5N1

Enrollment

Registered

2011-04-14

Start date

2011-04-30

Completion date

2012-09-30

Last updated

2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avian Influenza, Bird Flu

Keywords

Influenza, pandemic, avian influenza, H5N1, flu

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.

Interventions

BIOLOGICALND1.1

adenovirus with the dsRNA adjuvant, dried and put into capsules

BIOLOGICALPlacebo control

Capsules of the same size and shape as experimental groups

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026