Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum (ICC H1)
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ClinicalTrials.gov Identifier: NCT01761123 |
Recruitment Status :
Completed
First Posted : January 4, 2013
Last Update Posted : December 10, 2014
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Sponsor:
Vaxart
Information provided by (Responsible Party):
Vaxart
Tracking Information | |||||||
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First Submitted Date ICMJE | January 2, 2013 | ||||||
First Posted Date ICMJE | January 4, 2013 | ||||||
Last Update Posted Date | December 10, 2014 | ||||||
Study Start Date ICMJE | January 2013 | ||||||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: 1 year ] Frequency and magnitude of adverse events
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Immunogenicity [ Time Frame: 1 year ] Antibody and T cell responses to HA
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum | ||||||
Official Title ICMJE | An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of VXA-A1.1 by Delivery Directly to the Ileum Using the InteliSite Companion Capsule in Healthy Adult Males | ||||||
Brief Summary | the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of VXA-A1.1 oral vaccine. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Seasonal Influenza | ||||||
Intervention ICMJE | Biological: VXA-A1.1 | ||||||
Study Arms ICMJE | Experimental: VXA-A1.1
Intestinal Delivery
Intervention: Biological: VXA-A1.1
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
37 | ||||||
Original Estimated Enrollment ICMJE |
12 | ||||||
Actual Study Completion Date ICMJE | October 2014 | ||||||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 49 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01761123 | ||||||
Other Study ID Numbers ICMJE | VXA02-002 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Vaxart | ||||||
Study Sponsor ICMJE | Vaxart | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Vaxart | ||||||
Verification Date | December 2014 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |