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

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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Influenza
• Intervention / Treatment: Biological: VXA-A1.1

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States
      • Scintipharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VXA-A1.1; Intestinal Delivery	Biological: VXA-A1.1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Frequency and magnitude of adverse events	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity	Antibody and T cell responses to HA	1 year

Collaborators and Investigators

• Sponsor: Vaxart
• Investigators: Principal Investigator: Walter Doll, PhD, Scintipharma

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Prevention of Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: VXA02-002