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

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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.


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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