Immunogenicity of ND1.1 by Delivery Directly to the Ileum (ICC H5)

Vaxart

Status and phase: Completed; Phase 1

Conditions: Avian Influenza

Treatments: Biological: ND1.1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01698060

VXA01-001subA

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Intestinal Delivery

Experimental group

Description:

ND1.1

Treatment:

Biological: ND1.1