A Study of Immune Response to the Human Papillomavirus Vaccine in Young Women with Inflammatory Bowel Disease

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 09-000485
    NCT ID: NCT01034358
    Sponsor Protocol Number: 09-000485

About this study

The purpose of this study is to test the immune response to the Human Papillomavirus Vaccine in girls who have inflammatory bowel disease. The vaccine may not respond well in these girls, either due to having IBD or due to the immunosuppressants used to control IBD.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Female
  • Age 9-26 years
  • Has inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)

Exclusion Criteria

  • Pregnant
  • Taking corticosteroids
  • Allergy to yeast aluminum component of the HPV vaccine
  • Positive for all HPV types in the Gardasil vaccine—6, 11, 16, 18

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Jeanne Tung, M.D.

Closed for enrollment

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CLS-20312906

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