Back to resultsSafety Study of an Oral Vaccine to Prevent Seasonal Influenza
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VXA-A1.1 Oral Vaccine
VXA Placebo Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, H1N1, flu, seasonal
Eligibility Criteria
Inclusion Criteria:
- In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.
Exclusion Criteria:
- Positive for H1 influenza by HAI.
- Has had an influenza vaccine in the past 2 years.
- Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
- History of any confirmed or suspected immunodeficient or immunosuppressive condition
- 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 of the vaccine targeting the mucosa of the small intestine
- Use of proton pump inhibitors(Nexium, Prilosec).
- Stool sample with occult blood at baseline exam
Sites / Locations
- WCCT
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Low Dose VXA-A1.1 Oral Vaccine
VXA Placebo Tablet
Medium Dose VXA-A1.1 Oral Vaccine
High Dose VXA-A1.1 Oral Vaccine
Arm Description
Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.
Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design.
Two doses of replication incompetent adenovirus vaccine given in an oral tablet
One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003.
Outcomes
Primary Outcome Measures
Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events
Secondary Outcome Measures
Magnitude of humoral immune response to influenza as measured by functional assays
Magnitude of cellular immune responses to influenza as measured by functional assays
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01688297
Brief Title
Safety Study of an Oral Vaccine to Prevent Seasonal Influenza
Official Title
Randomized Phase 1 Double-Blinded Placebo Controlled Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Seasonal Influenza A Vaccine and dsRNA Adjuvant Administered Orally to Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vaxart
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).
Detailed Description
Low and mid dose study was conducted under protocol number VXA02-001
High dose study was conducted under protocol number VXA02-003
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, H1N1, flu, seasonal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose VXA-A1.1 Oral Vaccine
Arm Type
Experimental
Arm Description
Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.
Arm Title
VXA Placebo Tablet
Arm Type
Placebo Comparator
Arm Description
Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design.
Arm Title
Medium Dose VXA-A1.1 Oral Vaccine
Arm Type
Experimental
Arm Description
Two doses of replication incompetent adenovirus vaccine given in an oral tablet
Arm Title
High Dose VXA-A1.1 Oral Vaccine
Arm Type
Experimental
Arm Description
One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003.
Intervention Type
Biological
Intervention Name(s)
VXA-A1.1 Oral Vaccine
Other Intervention Name(s)
Ad-HA-dsRNA (VXA-A1.1)
Intervention Description
One or two doses of replication incompetent adenovirus oral tablet vaccine
Intervention Type
Biological
Intervention Name(s)
VXA Placebo Tablet
Other Intervention Name(s)
Placebo Control
Intervention Description
Off-white tablets similarly formulated to the active drug product tablets.
Primary Outcome Measure Information:
Title
Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events
Time Frame
One year following last vaccination
Secondary Outcome Measure Information:
Title
Magnitude of humoral immune response to influenza as measured by functional assays
Time Frame
28 Days and 180 Days post-vaccination
Title
Magnitude of cellular immune responses to influenza as measured by functional assays
Time Frame
28 Days and 180 Days post-vaccination
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:
Positive for H1 influenza by HAI.
Has had an influenza vaccine in the past 2 years.
Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
History of any confirmed or suspected immunodeficient or immunosuppressive condition
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 of the vaccine targeting the mucosa of the small intestine
Use of proton pump inhibitors(Nexium, Prilosec).
Stool sample with occult blood at baseline exam
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Liebowitz, MD, PhD
Organizational Affiliation
Vaxart, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Apinya Vutikullird, DO
Organizational Affiliation
WCCT
Official's Role
Principal Investigator
Facility Information:
Facility Name
WCCT
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26333337
Citation
Liebowitz D, Lindbloom JD, Brandl JR, Garg SJ, Tucker SN. High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial. Lancet Infect Dis. 2015 Sep;15(9):1041-1048. doi: 10.1016/S1473-3099(15)00266-2.
Results Reference
result
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Safety Study of an Oral Vaccine to Prevent Seasonal Influenza
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