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CompletedNCT01698060ICC H5Updated Dec 10, 2014

Immunogenicity of ND1.1 by Delivery Directly to the Ileum

A Phase 1 interventional study of ND1.1 in Avian Influenza, sponsored by Vaxart. Completed at 1 site in United States. Open to male participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-10.

Sponsored by Vaxart · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 49 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Avian Influenza

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Keywords

  • Prevention of Avian Influenza
03

In context

Influenza in Birds

113 studies on the registry are indexed under Influenza in Birds; 3 are open to participants now.

This study's enrollment of 12 is below the median of 157 across 103 interventional studies indexed under Influenza in Birds.

Browse Influenza in Birds studies →

Lead sponsor

Vaxart is the lead sponsor of 23 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Intestinal Delivery

    ND1.1

    Biological: ND1.1

Interventions

  • BiologicalND1.1
06

What researchers measure

Primary outcomes

  1. Safety

    Frequency and magnitude of adverse events

    Time frame: 1 year

Secondary outcomes

  1. Immunogenicity

    Antibody and T cell responses to HA

    Time frame: 1 year

07

Study locations

1 site
  • Scintipharma
    Lexington, Kentucky, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01698060
Lead sponsor
Vaxart
Responsible party
Sponsor
First posted
Oct 2, 2012
Start date
Sep 2012
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Dec 10, 2014

Study contacts

David Liebowitz, MD, PhD
study director · Vaxart, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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