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
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 29, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedDecember 10, 2014
December 1, 2014
1.2 years
September 29, 2012
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Frequency and magnitude of adverse events
1 year
Secondary Outcomes (1)
Immunogenicity
1 year
Study Arms (1)
Intestinal Delivery
EXPERIMENTALND1.1
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vaxartlead
Study Sites (1)
Scintipharma
Lexington, Kentucky, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Liebowitz, MD, PhD
Vaxart, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2012
First Posted
October 2, 2012
Study Start
September 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
December 10, 2014
Record last verified: 2014-12