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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01034358
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Merck Sharp & Dohme Corp.
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Uterine Cervical Dysplasia Biological: Human Papillomavirus Vaccine Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease
Study Start Date : February 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Human Papillomavirus Vaccine
The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Biological: Human Papillomavirus Vaccine
0.5mL intramuscular for 3 doses at 0, 2, and 6 months
Other Name: Gardasil

Primary Outcome Measures :
  1. Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) [ Time Frame: One year ]
    Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Women 9-26 years of age
  2. Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)

Exclusion Criteria:

  1. Pregnancy
  2. Taking corticosteroids
  3. Allergy to yeast aluminum component of the HPV vaccine
  4. Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01034358

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Merck Sharp & Dohme Corp.
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Principal Investigator: Jeanne Tung, MD Mayo Clinic
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Responsible Party: Jeanne Tung, MD, Mayo Clinic Identifier: NCT01034358    
Other Study ID Numbers: 09-000485
First Posted: December 17, 2009    Key Record Dates
Results First Posted: October 23, 2012
Last Update Posted: October 23, 2012
Last Verified: September 2012
Keywords provided by Mayo Clinic:
inflammatory bowel disease
Crohn disease
ulcerative colitis
Papillomavirus vaccines
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type