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

V

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

37 participants in 1 patient group

VXA-A1.1
Experimental group
Description:
Intestinal Delivery
Treatment:
Biological: VXA-A1.1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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