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

Primary Purpose

Inflammatory Bowel Disease, Uterine Cervical Dysplasia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Human Papillomavirus Vaccine
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Disease focused on measuring inflammatory bowel disease, Crohn disease, ulcerative colitis, Papillomavirus vaccines

Eligibility Criteria

9 Years - 26 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Human Papillomavirus Vaccine

Arm Description

The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 10, 2009
Last Updated
September 21, 2012
Sponsor
Mayo Clinic
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01034358
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Uterine Cervical Dysplasia
Keywords
inflammatory bowel disease, Crohn disease, ulcerative colitis, Papillomavirus vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Human Papillomavirus Vaccine
Arm Type
Experimental
Arm Description
The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Intervention Type
Biological
Intervention Name(s)
Human Papillomavirus Vaccine
Other Intervention Name(s)
Gardasil
Intervention Description
0.5mL intramuscular for 3 doses at 0, 2, and 6 months
Primary Outcome Measure Information:
Title
Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])
Description
Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne Tung, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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