Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
ICC H1
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
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 2, 2013
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 10, 2014
December 1, 2014
1.7 years
January 2, 2013
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Frequency and magnitude of adverse events
1 year
Secondary Outcomes (1)
Immunogenicity
1 year
Study Arms (1)
VXA-A1.1
EXPERIMENTALIntestinal Delivery
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vaxartlead
Study Sites (1)
Scintipharma
Lexington, Kentucky, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Doll, PhD
Scintipharma
- STUDY DIRECTOR
David Liebowitz, MD, PhD
Vaxart, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2013
First Posted
January 4, 2013
Study Start
January 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 10, 2014
Record last verified: 2014-12