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Immunogenicity of ND1.1 by Delivery Directly to the Ileum (ICC H5)

This study is currently recruiting participants.
Verified September 2012 by Vaxart
Sponsor:
Information provided by (Responsible Party):
Vaxart
ClinicalTrials.gov Identifier:
NCT01698060
First received: September 29, 2012
Last updated: October 1, 2012
Last verified: September 2012
History of Changes

September 29, 2012
October 1, 2012
September 2012
April 2013   (final data collection date for primary outcome measure)
Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Frequency and magnitude of adverse events
Same as current
Complete list of historical versions of study NCT01698060 on ClinicalTrials.gov Archive Site
Immunogenicity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Antibody and T cell responses to HA
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Avian Influenza
Biological: ND1.1
Experimental: Intestinal Delivery
ND1.1
Intervention: Biological: ND1.1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2013
April 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 49 Years
Yes
Not Provided
United States
 
NCT01698060
VXA01-001subA
No
Vaxart
Vaxart
Not Provided
Study Director: David Liebowitz, MD, PhD Vaxart, Inc.
Vaxart
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP