Immunogenicity of ND1.1 by Delivery Directly to the Ileum (NCT01698060) | Clinical Trial Compass
CompletedPhase 1
Immunogenicity of ND1.1 by Delivery Directly to the Ileum
United States12 participantsStarted 2012-09
Plain-language summary
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.
Who can participate
Age range18 Years – 49 Years
SexMALE
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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