Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease
Although guidelines exist for immunization of patients with inflammatory bowel disease, few
studies exist demonstrating vaccine efficacy in this population. In patients with
inflammatory bowel disease, lower than normal humoral responses have been shown with the
tetanus toxoid booster, oral cholera, and influenza vaccinations. It is currently uncertain
whether women with inflammatory bowel disease (IBD) have an increased risk of cervical
dysplasia and cancer. Gardasil, a vaccine against human papilloma viruses (HPV) 6, 11, 16,
and 18, has been approved for the prevention of cervical dysplasias and cancers in women
ages 9-26 years. However, its immune response in immunocompromised or immunosuppressed
patients is unknown.
Young women with inflammatory bowel disease who have not received the HPV vaccine will
receive the vaccine. The vaccine is given in 3 doses over 6 months. Response to the
vaccine will be measured 6 months after completing the vaccine series.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])
Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).
Jeanne Tung, MD
United States: Institutional Review Board
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