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OpenTrials
Completed

NCT Number: NCT01761123

Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum

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.

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Key information

Conditions

Seasonal Influenza

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Scintipharma

Lexington, Kentucky, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VXA-A1.1

Biological

Primary outcomes

  1. Safety

    Time frame: 1 year

    Frequency and magnitude of adverse events

Secondary outcomes

  1. Immunogenicity

    Time frame: 1 year

    Antibody and T cell responses to HA

Sponsors and collaborators

Lead sponsor

Vaxart

Industry

Registry information

Official study title

An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of VXA-A1.1 by Delivery Directly to the Ileum Using the InteliSite Companion Capsule in Healthy Adult Males

Acronym: ICC H1

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 4, 2013
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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