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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014