Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
Completed · Phase 1
Conditions studied: Seasonal Influenza
In brief
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.
Key facts
- Study ID
- NCT01761123
- Run by
- Vaxart
- People needed
- 37
- Starts
- 2013-01-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2014-12-10
Who can join
Age: 18 and older, up to 49. Sex: male. Healthy volunteers: accepted.
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
Where it is running
- Scintipharma — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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