NCT01034358

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 9 Years – 26 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Disease
• Uterine Cervical Dysplasia

Interventions

Type	Name	Description
BIOLOGICAL	Human Papillomavirus Vaccine	0.5mL intramuscular for 3 doses at 0, 2, and 6 months

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-12-17
• Last updated: 2012-10-23
• Results posted: 2012-10-23

Locations

1 site across 1 country: United States