Immunogenicity of ND1.1 by Delivery Directly to the Ileum (ICC H5)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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Ages Eligible for Study:
18 Years to 49 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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