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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Inflammatory Bowel Disease; Uterine Cervical Dysplasia

Treatments: Biological: Human Papillomavirus Vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01034358

09-000485

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 9 to 26 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Human Papillomavirus Vaccine

Experimental group

Description:

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

Treatment:

Biological: Human Papillomavirus Vaccine