Immunogenicity of ND1.1 by Delivery Directly to the Ileum (ICC H5)
This study is currently recruiting participants.
Verified September 2012 by Vaxart
Sponsor:
Vaxart
Information provided by (Responsible Party):
Vaxart
ClinicalTrials.gov Identifier:
NCT01698060
First received: September 29, 2012
Last updated: October 1, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Avian Influenza |
Biological: ND1.1 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Vaxart:
Primary Outcome Measures:
- Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Frequency and magnitude of adverse events
Secondary Outcome Measures:
- Immunogenicity [ Time Frame: 1 year ] [ Designated as safety issue: No ]Antibody and T cell responses to HA
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intestinal Delivery
ND1.1
|
Biological: ND1.1 |
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698060
Locations
| United States, Kentucky | |
| Scintipharma | Recruiting |
| Lexington, Kentucky, United States | |
| Contact: Erik Sandefer esandefer@scintipharma.com | |
| Principal Investigator: Walter Doll, PhD | |
Sponsors and Collaborators
Vaxart
Investigators
| Study Director: | David Liebowitz, MD, PhD | Vaxart, Inc. |
More Information
No publications provided
| Responsible Party: | Vaxart |
| ClinicalTrials.gov Identifier: | NCT01698060 History of Changes |
| Other Study ID Numbers: | VXA01-001subA |
| Study First Received: | September 29, 2012 |
| Last Updated: | October 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vaxart:
|
Prevention of Avian Influenza |
Additional relevant MeSH terms:
|
Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013