Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum (ICC H1)

Vaxart

Status and phase

Completed

Phase 1

Conditions

Seasonal Influenza

Treatments

Biological: VXA-A1.1

Study type

Interventional

Funder types

Industry

Identifiers

NCT01761123

VXA02-002

Details and patient eligibility

About

the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based 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 VXA-A1.1 oral vaccine.

Enrollment

37 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

Not able to donate up to 550 ml of blood over several months
Exposure to an investigational drug or vaccine 8 weeks prior to study
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 implantable device that is sensitive to radio frequencies ( e.g. pacemakers)
History of 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