Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum (ICC H1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vaxart
ClinicalTrials.gov Identifier:
NCT01761123
First received: January 2, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based 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 VXA-A1.1 oral vaccine.


Condition Intervention Phase
Seasonal Influenza
Biological: VXA-A1.1
Phase 1

Study Type: Interventional
Study Design: 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 VXA-A1.1 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: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VXA-A1.1
Intestinal Delivery
Biological: VXA-A1.1

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders 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:

  • Not able to donate up to 550 ml of blood over several months
  • Exposure to an investigational drug or vaccine 8 weeks prior to study
  • 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 implantable device that is sensitive to radio frequencies ( e.g. pacemakers)
  • History of 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 ClinicalTrials.gov identifier: NCT01761123

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

No publications provided

Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT01761123     History of Changes
Other Study ID Numbers: VXA02-002
Study First Received: January 2, 2013
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vaxart:
Prevention of Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014