Immunogenicity of ND1.1 by Delivery Directly to the Ileum
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 49 |
Updated: | 2/7/2015 |
Start Date: | September 2012 |
End Date: | December 2013 |
An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of ND1.1 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 ND1.1, an adjuvanted
adenoviral-based avian 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 ND1.1 oral vaccine.
adenoviral-based avian 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 ND1.1 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:
- Ability to donate up to 550 ml of blood over several months
- Exposure to any investigational drug or vaccine 8 weeks prior to study
- Has traveled to Asia within 8 weeks of enrollment
- 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 an implantable device that is sensitive to radio frequencies (e.g.
pacemakers)
- History of an 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
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