ICC H1: Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum

• Sponsor: Vaxart (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01761123
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jan 1, 2013
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety [1 year]

   Frequency and magnitude of adverse events

Secondary Outcome Measures

1. Immunogenicity [1 year]

   Antibody and T cell responses to HA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Scintipharma	Lexington	Kentucky	United States

Sponsors and Collaborators

• Vaxart

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vaxart
• ClinicalTrials.gov Identifier: NCT01761123
• Other Study ID Numbers: VXA02-002
• First Posted: Jan 4, 2013
• Last Update Posted: Dec 10, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Vaxart: Prevention of Influenza
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Dec 10, 2014