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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01698060
First Posted: October 2, 2012
Last Update Posted: December 10, 2014
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Vaxart
  Purpose
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.

Condition Intervention Phase
Avian Influenza Biological: ND1.1 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Vaxart:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 year ]
    Frequency and magnitude of adverse events


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 1 year ]
    Antibody and T cell responses to HA


Enrollment: 12
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intestinal Delivery
ND1.1
Biological: ND1.1

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698060


Locations
United States, Kentucky
Scintipharma
Lexington, Kentucky, United States
Sponsors and Collaborators
Vaxart
Investigators
Study Director: David Liebowitz, MD, PhD Vaxart, Inc.
  More Information

Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT01698060     History of Changes
Other Study ID Numbers: VXA01-001subA
First Submitted: September 29, 2012
First Posted: October 2, 2012
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Vaxart:
Prevention of Avian Influenza

Additional relevant MeSH terms:
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases