Back to resultsImmunogenicity of Seasonal Influenza by Delivery Directly to Ileum (ICC H1)
Primary Purpose
Seasonal Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VXA-A1.1
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Influenza focused on measuring Prevention of Influenza
Eligibility Criteria
Inclusion Criteria:
- Able and willing to complete informed consent
- Healthy, as established by medical history, physical exam, and laboratory assessments
- Has normal bowel movements
- Willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge
Exclusion Criteria:
- Not able to donate up to 550 ml of blood over several months
- Exposure to an investigational drug or vaccine 8 weeks prior to study
- Abnormal ECG findings
- History of irritable bowl or any other inflammatory gastrointestinal disorder
- Any individual with increased risk for bowl obstruction
- Radiation exposure above target values 50 mSv within the past 30 days or a cumulative dose above 150 mSV in the past 12 months
- History of substance abuse
- Subject unwilling to use an approved method of contraception during study and for 2 months after study
- Positive for HCV, HIV, or HBV
- Presence of implantable device that is sensitive to radio frequencies ( e.g. pacemakers)
- History of autoimmune disorder, or an immunosuppressive disorder
- Stool sample with occult blood at baseline
- Any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator is a contraindication to the compliance of the protocol or informed consent
Sites / Locations
- Scintipharma
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VXA-A1.1
Arm Description
Intestinal Delivery
Outcomes
Primary Outcome Measures
Safety
Frequency and magnitude of adverse events
Secondary Outcome Measures
Immunogenicity
Antibody and T cell responses to HA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01761123
Brief Title
Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
Acronym
ICC H1
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza
Keywords
Prevention of Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VXA-A1.1
Arm Type
Experimental
Arm Description
Intestinal Delivery
Intervention Type
Biological
Intervention Name(s)
VXA-A1.1
Primary Outcome Measure Information:
Title
Safety
Description
Frequency and magnitude of adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
Antibody and T cell responses to HA
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Able and willing to complete informed consent
Healthy, as established by medical history, physical exam, and laboratory assessments
Has normal bowel movements
Willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge
Exclusion Criteria:
Not able to donate up to 550 ml of blood over several months
Exposure to an investigational drug or vaccine 8 weeks prior to study
Abnormal ECG findings
History of irritable bowl or any other inflammatory gastrointestinal disorder
Any individual with increased risk for bowl obstruction
Radiation exposure above target values 50 mSv within the past 30 days or a cumulative dose above 150 mSV in the past 12 months
History of substance abuse
Subject unwilling to use an approved method of contraception during study and for 2 months after study
Positive for HCV, HIV, or HBV
Presence of implantable device that is sensitive to radio frequencies ( e.g. pacemakers)
History of autoimmune disorder, or an immunosuppressive disorder
Stool sample with occult blood at baseline
Any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator is a contraindication to the compliance of the protocol or informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Doll, PhD
Organizational Affiliation
Scintipharma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Liebowitz, MD, PhD
Organizational Affiliation
Vaxart, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Scintipharma
City
Lexington
State/Province
Kentucky
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
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