Immunogenicity of ND1.1 by Delivery Directly to the Ileum

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01698060

Acronym

ICC H5

Enrollment

Registered

2012-10-02

Start date

2012-09-30

Completion date

2013-11-30

Last updated

2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avian Influenza

Keywords

Prevention of Avian Influenza

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.

Interventions

BIOLOGICALND1.1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 49 Years

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Safety	1 year	Frequency and magnitude of adverse events

Secondary

Measure	Time frame	Description
Immunogenicity	1 year	Antibody and T cell responses to HA

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026