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

Phase 4

Completed

• Conditions: Inflammatory Bowel Disease; Uterine Cervical Dysplasia
• Interventions: Biological: Human Papillomavirus Vaccine

• Registration Number: NCT01034358
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Study Start: 2010-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-09
• Results First Submitted: 2012-09-21
• Results First Submitted QC: 2012-09-21
• Last Update Submitted: 2012-09-21
• Results First Posted: 2012-10-23
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1. Women 9-26 years of age
2. Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human Papillomavirus Vaccine	Human Papillomavirus Vaccine	The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States