Back to resultsSafety Study of an Oral Vaccine to Prevent Avian Influenza (H5N1)
Primary Purpose
Avian Influenza, Bird Flu
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ND1.1
Placebo control
Sponsored by
About this trial
This is an interventional prevention trial for Avian Influenza focused on measuring Influenza, pandemic, avian influenza, H5N1, flu
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Experimental Low Dose
Experimental Medium Dose
Experimental High Dose
Placebo Control
Arm Description
Biological: One dose of a live replication incompetent adenovirus given in a capsule
Biological: One or two doses of replication incompetent adenovirus given in a capsule Other: Placebo capsules of the same size and shape
Biological: One dose of replication incompetent adenovirus in a capsule
Capsules of the same size and shape as the experimental
Outcomes
Primary Outcome Measures
Frequency or severity of vaccine related events as measured through reported AEs
Secondary Outcome Measures
Magnitude of humoral immune responses to avian influenza as measured by functional assays
Magnitude of cellular immune responses to avian influenza as measured by functional assays
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01335347
Brief Title
Safety Study of an Oral Vaccine to Prevent Avian Influenza
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vaxart
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avian Influenza, Bird Flu
Keywords
Influenza, pandemic, avian influenza, H5N1, flu
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Low Dose
Arm Type
Experimental
Arm Description
Biological: One dose of a live replication incompetent adenovirus given in a capsule
Arm Title
Experimental Medium Dose
Arm Type
Experimental
Arm Description
Biological: One or two doses of replication incompetent adenovirus given in a capsule
Other: Placebo capsules of the same size and shape
Arm Title
Experimental High Dose
Arm Type
Experimental
Arm Description
Biological: One dose of replication incompetent adenovirus in a capsule
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Capsules of the same size and shape as the experimental
Intervention Type
Biological
Intervention Name(s)
ND1.1
Other Intervention Name(s)
Ad-HA-dsRNA
Intervention Description
adenovirus with the dsRNA adjuvant, dried and put into capsules
Intervention Type
Biological
Intervention Name(s)
Placebo control
Intervention Description
Capsules of the same size and shape as experimental groups
Primary Outcome Measure Information:
Title
Frequency or severity of vaccine related events as measured through reported AEs
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Magnitude of humoral immune responses to avian influenza as measured by functional assays
Time Frame
up to 1 year
Title
Magnitude of cellular immune responses to avian influenza as measured by functional assays
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean N Tucker, PhD
Organizational Affiliation
Vaxart
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin Kabongo, MD, PhD
Organizational Affiliation
Accelovance
Official's Role
Principal Investigator
Facility Information:
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23357198
Citation
Peters W, Brandl JR, Lindbloom JD, Martinez CJ, Scallan CD, Trager GR, Tingley DW, Kabongo ML, Tucker SN. Oral administration of an adenovirus vector encoding both an avian influenza A hemagglutinin and a TLR3 ligand induces antigen specific granzyme B and IFN-gamma T cell responses in humans. Vaccine. 2013 Mar 25;31(13):1752-8. doi: 10.1016/j.vaccine.2013.01.023. Epub 2013 Jan 25.
Results Reference
derived
Learn more about this trial
Safety Study of an Oral Vaccine to Prevent Avian Influenza
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