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

Primary Purpose

Avian Influenza

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ND1.1

About this trial

This is an interventional prevention trial for Avian Influenza focused on measuring Prevention of Avian Influenza

Eligibility Criteria

18 Years - 49 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Scintipharma

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intestinal Delivery

Arm Description

ND1.1

Outcomes

Primary Outcome Measures

Safety

Frequency and magnitude of adverse events

Secondary Outcome Measures

Immunogenicity

Antibody and T cell responses to HA

Full Information

NCT ID

NCT01698060

First Posted

September 29, 2012

Last Updated

December 8, 2014

Sponsor

Vaxart

1. Study Identification

Unique Protocol Identification Number

NCT01698060

Brief Title

Immunogenicity of ND1.1 by Delivery Directly to the Ileum

Acronym

ICC H5

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vaxart

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Avian Influenza

Keywords

Prevention of Avian Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intestinal Delivery

Arm Type

Experimental

Arm Description

ND1.1

Intervention Type

Biological

Intervention Name(s)

ND1.1

Primary Outcome Measure Information:

Title

Safety

Description

Frequency and magnitude of adverse events

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Immunogenicity

Description

Antibody and T cell responses to HA

Time Frame

1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Liebowitz, MD, PhD

Organizational Affiliation

Vaxart, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Scintipharma

City

Lexington

State/Province

Kentucky

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity of ND1.1 by Delivery Directly to the Ileum

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