Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Children's Hospital
With
Harvard School of Public Health (HSPH)
Merck Sharp & Dohme LLC
Age
9–26
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Crohn's disease, ulcerative colitis, or indeterminate colitis diagnosed by standard clinical, radiographic, endoscopic, and histologic criteria.
2. 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.
3. Female gender
4. Age 9-26 years
5. Patient (18 years old) or parent is willing to provide informed consent.
6. 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
You may not be if
1. Male gender
2. Unwilling to provide consent
3. New immunomodulator added within the last 30 days, and was not previously on any immunomodulator
4. 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)
5. Hypersensitivity to the ingredients/components of the vaccine (e.g., aluminum, yeast)
6. 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.
7. Previously received HPV vaccination.
Clareo Health | Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy
