Immunogenicity of ND1.1 by Delivery Directly to the Ileum

Completed · Phase 1

Conditions studied: Avian Influenza

In brief

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.

Key facts

Study ID

NCT01698060

Run by

Vaxart

People needed

12

Starts

2012-09-01

Expected to finish

2013-11-01

Last updated by the study team

2014-12-10

Who can join

Age: 18 and older, up to 49. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scintipharma — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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