Immunogenicity of ND1.1 by Delivery Directly to the Ileum

Phase 1

Completed

• Conditions: Avian Influenza
• Interventions: Biological: ND1.1

• Registration Number: NCT01698060
• Lead Sponsor: Vaxart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-29
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intestinal Delivery	ND1.1	ND1.1

Primary Outcome Measures

Name	Time	Method
Safety	1 year	Frequency and magnitude of adverse events

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	1 year	Antibody and T cell responses to HA

Trial Locations

Locations (1)

Scintipharma; 🇺🇸 Lexington, Kentucky, United States