Immunogenicity of ND1.1 by Delivery Directly to the Ileum

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