Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	Merck
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01034358

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: Gardasil HPV 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:

Genetics Home Reference related topics: Crohn disease

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

The magnitude of antibody response to the HPV vaccine in young women with inflammatory bowel disease enrolled in this trial will be compared to the magnitude of antibody response in young women without IBD (historical controls) [ Time Frame: one year for each study subject, 3 years for the entire study ] [ Designated as safety issue: No ]

Estimated Enrollment:	195
Study Start Date:	February 2010
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Inflammatory Bowel Disease The response to the Gardasil vaccine in women with inflammatory bowel disease will be compared to historical response rates in prior safety and efficacy trials of the Gardasil vaccine.	Biological: Gardasil HPV vaccine 0.5mL intramuscular for 3 doses at 0, 2, and 6 months Other Name: Human Papillomavirus vaccine

Detailed Description:

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:

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

Contacts and Locations

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

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
Last Updated:	June 6, 2011
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:

Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Inflammatory Bowel Diseases
Intestinal Diseases
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases

Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 24, 2012