Immunogenicity of ND1.1 by Delivery Directly to the Ileum (ICC H5)

An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of ND1.1 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 ND1.1, an adjuvanted adenoviral-based avian 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 ND1.1 oral vaccine.

Study Overview

• Status: Completed
• Conditions: Avian Influenza
• Intervention / Treatment: Biological: ND1.1

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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:

• Ability to donate up to 550 ml of blood over several months
• Exposure to any investigational drug or vaccine 8 weeks prior to study
• Has traveled to Asia within 8 weeks of enrollment
• 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 an implantable device that is sensitive to radio frequencies (e.g. pacemakers)
• History of an 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: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intestinal Delivery; ND1.1	Biological: ND1.1

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

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: September 29, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (ESTIMATE): October 2, 2012

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 Avian Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Orthomyxoviridae Infections; Influenza in Birds
• Other Study ID Numbers: VXA01-001subA