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

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

Tracking Information

• First Submitted Date: January 2, 2013
• First Posted Date: January 4, 2013
• Last Update Posted Date: December 10, 2014
• Study Start Date: January 2013
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2013)

Safety [ Time Frame: 1 year ]

Frequency and magnitude of adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 3, 2013)

Immunogenicity [ Time Frame: 1 year ]

Antibody and T cell responses to HA

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Seasonal Influenza
• Intervention: Biological: VXA-A1.1

Study Arms

Experimental: VXA-A1.1

Intestinal Delivery

Intervention: Biological: VXA-A1.1

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 8, 2014): 37
• Original Estimated Enrollment (submitted: January 3, 2013): 12
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01761123
• Other Study ID Numbers: VXA02-002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Vaxart
• Study Sponsor: Vaxart
• Collaborators: Not Provided

Investigators

• Principal Investigator: Walter Doll, PhD; Scintipharma
• Study Director: David Liebowitz, MD, PhD; Vaxart, Inc.

• PRS Account: Vaxart
• Verification Date: December 2014