Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 3/1/2014 |
| Start Date: | January 2013 |
| End Date: | February 2014 |
| Contact: | Erik Sandefer |
| Email: | esandefer@scintipharma.com |
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
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.
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.
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
We found this trial at
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