Know Cancer

or
forgot password

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


Phase 4
9 Years
26 Years
Not Enrolling
Female
Inflammatory Bowel Disease, Uterine Cervical Dysplasia

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])

Outcome Description:

Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Jeanne Tung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

09-000485

NCT ID:

NCT01034358

Start Date:

February 2010

Completion Date:

June 2011

Related Keywords:

  • Inflammatory Bowel Disease
  • Uterine Cervical Dysplasia
  • inflammatory bowel disease
  • Crohn disease
  • ulcerative colitis
  • Papillomavirus vaccines
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Inflammatory Bowel Diseases
  • Intestinal Diseases

Name

Location

Mayo ClinicRochester, Minnesota  55905