Immunogenicity of ND1.1 by Delivery Directly to the Ileum

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Avian Influenza

Intervention / Treatment
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* Biological: ND1.1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intestinal Delivery<br>ND1.1 | Biological: ND1.1<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Frequency and magnitude of adverse events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | Antibody and T cell responses to HA | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of Avian Influenza