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

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

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    Frequency and magnitude of adverse events

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Antibody and T cell responses to HA

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


Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Please refer to this study by its identifier: NCT01698060

United States, Kentucky
Scintipharma Recruiting
Lexington, Kentucky, United States
Contact: Erik Sandefer   
Principal Investigator: Walter Doll, PhD         
Sponsors and Collaborators
Study Director: David Liebowitz, MD, PhD Vaxart, Inc.
  More Information

No publications provided

Responsible Party: Vaxart Identifier: NCT01698060     History of Changes
Other Study ID Numbers: VXA01-001subA
Study First Received: September 29, 2012
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vaxart:
Prevention of Avian Influenza

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on April 22, 2014