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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01034358
First received: December 10, 2009
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Inflammatory Bowel Disease
Uterine Cervical Dysplasia
Biological: Human Papillomavirus Vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) [ Time Frame: One year ] [ Designated as safety issue: No ]
    Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).


Enrollment: 15
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   9 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034358

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jeanne Tung, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Jeanne Tung, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01034358     History of Changes
Other Study ID Numbers: 09-000485
Study First Received: December 10, 2009
Results First Received: September 21, 2012
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
inflammatory bowel disease
Crohn disease
ulcerative colitis
Papillomavirus vaccines

Additional relevant MeSH terms:
Genital Diseases, Female
Cervical Intraepithelial Neoplasia
Inflammatory Bowel Diseases
Intestinal Diseases
Uterine Cervical Dysplasia
Carcinoma
Carcinoma in Situ
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases

ClinicalTrials.gov processed this record on October 29, 2014