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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01034358
Other study ID # 09-000485
Secondary ID
Status Completed
Phase Phase 4
First received December 10, 2009
Last updated September 21, 2012
Start date February 2010
Est. completion date June 2011

Study information

Verified date September 2012
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Female
Age group 9 Years to 26 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Human Papillomavirus Vaccine
0.5mL intramuscular for 3 doses at 0, 2, and 6 months

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). One year No
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