Safety Study of an Oral Vaccine to Prevent Avian Influenza (H5N1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vaxart
ClinicalTrials.gov Identifier:
NCT01335347
First received: April 10, 2011
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Avian Influenza
Bird Flu
Biological: ND1.1
Biological: Placebo control
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Vaxart:

Primary Outcome Measures:
  • Frequency or severity of vaccine related events as measured through reported AEs [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Magnitude of humoral immune responses to avian influenza as measured by functional assays [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Magnitude of cellular immune responses to avian influenza as measured by functional assays [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: April 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Low Dose
Biological: One dose of a live replication incompetent adenovirus given in a capsule
Biological: ND1.1
adenovirus with the dsRNA adjuvant, dried and put into capsules
Other Name: Ad-HA-dsRNA
Experimental: Experimental Medium Dose

Biological: One or two doses of replication incompetent adenovirus given in a capsule

Other: Placebo capsules of the same size and shape

Biological: ND1.1
adenovirus with the dsRNA adjuvant, dried and put into capsules
Other Name: Ad-HA-dsRNA
Experimental: Experimental High Dose
Biological: One dose of replication incompetent adenovirus in a capsule
Biological: ND1.1
adenovirus with the dsRNA adjuvant, dried and put into capsules
Other Name: Ad-HA-dsRNA
Placebo Comparator: Placebo Control
Capsules of the same size and shape as the experimental
Biological: Placebo control
Capsules of the same size and shape as experimental groups

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335347

Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
Vaxart
Investigators
Study Director: Sean N Tucker, PhD Vaxart
Principal Investigator: Martin Kabongo, MD, PhD Accelovance
  More Information

No publications provided by Vaxart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT01335347     History of Changes
Other Study ID Numbers: VXA01-001
Study First Received: April 10, 2011
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vaxart:
Influenza
pandemic
avian influenza
H5N1
flu

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014