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

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.
 
ClinicalTrials.gov Identifier: NCT01761123
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Vaxart

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Seasonal Influenza Biological: VXA-A1.1 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
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 VXA-A1.1 by Delivery Directly to the Ileum Using the InteliSite Companion Capsule in Healthy Adult Males
Study Start Date : January 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
Experimental: VXA-A1.1
Intestinal Delivery
 Biological: VXA-A1.1


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


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


Eligibility Criteria
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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:

  • 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
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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): NCT01761123


Locations
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United States, Kentucky
Scintipharma
Lexington, Kentucky, United States
Sponsors and Collaborators
Vaxart
Investigators
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Principal Investigator: Walter Doll, PhD Scintipharma
Study Director: David Liebowitz, MD, PhD Vaxart, Inc.
More Information
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Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT01761123    
Other Study ID Numbers: VXA02-002
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014
Keywords provided by Vaxart:
Prevention of Influenza
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases