Immunogenicity of ND1.1 by Delivery Directly to the Ileum

Avian Influenza Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698060
• Other study ID #: VXA01-001subA
• Status: Completed
• Phase: Phase 1
• First received: September 29, 2012
• Last updated: December 8, 2014
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avian Influenza

Intervention

Biological:
• ND1.1

Locations

Country	Name	City	State
United States	Scintipharma	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Vaxart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Frequency and magnitude of adverse events	1 year	Yes
Secondary	Immunogenicity	Antibody and T cell responses to HA	1 year	No