Status:
COMPLETED
Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
Merck Sharp & Dohme LLC
Conditions:
Inflammatory Bowel Disease
Eligibility:
FEMALE
9-26 years
Phase:
NA
Brief Summary
Many IBD patients take immunosuppressive agents and we are uncertain as to their capacity to mount a truly protective response after vaccination. If IBD patients do not have an adequate immunological ...
Eligibility Criteria
Inclusion
- Crohn's disease, ulcerative colitis, or indeterminate colitis diagnosed by standard clinical, radiographic, endoscopic, and histologic criteria.
- Actively followed by a physician at the Children's' Hospital gastroenterology (GI) or IBD Center, or patient is referred by local clinic or hospital for our study.
- Female gender
- Age 9-26 years
- Patient (18 years old) or parent is willing to provide informed consent.
- Is currently on an immunomodulator and/or TNF inhibitor for ≥ 30 days prior to enrollment. Patients may also be using prednisone or aminosalicylates in addition to the immunomodulator or TNF inhibitor. Standard concomitant medications (e.g. antibiotics, antihistamines, acetaminophen) will be allowed
Exclusion
- Male gender
- Unwilling to provide consent
- New immunomodulator added within the last 30 days, and was not previously on any immunomodulator
- History of bleeding disorder that would make hematoma likely (e.g., hemophilia, von Willebrand's disease) or on anti-coagulation therapy (certain cases may be allowed; each case will be assessed by study doctor)
- Hypersensitivity to the ingredients/components of the vaccine (e.g., aluminum, yeast)
- Known pregnancy or positive pregnancy test. We will obtain a urinary pregnancy test before each dose of the vaccine is administered. Subjects participating will be informed during the consent/assent procedures that the safety of this vaccine has not been proven in pregnant women, and will be advised not to become pregnant during the study and counseled according to the guidelines of the Children's Hospital IRB.
- Previously received HPV vaccination.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00727636
Start Date
July 1 2008
End Date
April 1 2011
Last Update
May 27 2011
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115