Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women. Women with inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to having IBD or due to immunosuppressants used to control IBD. This study will test how well women with IBD respond to the Gardasil vaccine.

Detailed Description
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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.

Official Title
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Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Disease, Uterine Cervical Dysplasia

Intervention / Treatment
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* Biological: Human Papillomavirus Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 9-26 years of age Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis) Exclusion Criteria: Pregnancy Taking corticosteroids Allergy to yeast aluminum component of the HPV vaccine Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Papillomavirus Vaccine<br>The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months. | Biological: Human Papillomavirus Vaccine<br>* 0.5mL intramuscular for 3 doses at 0, 2, and 6 months<br>* Other names: Gardasil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory bowel disease, Crohn disease, ulcerative colitis, Papillomavirus vaccines