Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease
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|ClinicalTrials.gov Identifier: NCT01034358|
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : October 23, 2012
Last Update Posted : October 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease Uterine Cervical Dysplasia||Biological: Human Papillomavirus Vaccine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Human Papillomavirus Vaccine
The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Biological: Human Papillomavirus Vaccine
0.5mL intramuscular for 3 doses at 0, 2, and 6 months
Other Name: Gardasil
- Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) [ Time Frame: One year ]Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034358
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Jeanne Tung, MD||Mayo Clinic|