Brief Title
Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease
Official Title
Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease
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.
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])
Condition
Inflammatory Bowel Disease
Intervention
Human Papillomavirus Vaccine
Study Arms / Comparison Groups
Human Papillomavirus Vaccine
Description: The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
15
Start Date
February 2010
Completion Date
June 2011
Primary Completion Date
June 2011
Eligibility Criteria
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
Gender
Female
Ages
9 Years - 26 Years
Accepts Healthy Volunteers
No
Contacts
Jeanne Tung, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01034358
Organization ID
09-000485
Study Sponsor
Mayo Clinic
Collaborators
Merck Sharp & Dohme LLC
Study Sponsor
Jeanne Tung, MD, Principal Investigator, Mayo Clinic
Verification Date
September 2012