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Pilot Study of Immunogenicity and Tolerability to the Quadrivalent Human Papillomavirus Virus-like Particle (VLP) Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy Compared to Healthy Children and Youth Adult Females


N/A
9 Years
26 Years
Not Enrolling
Female
Inflammatory Bowel Disease

Thank you

Trial Information

Pilot Study of Immunogenicity and Tolerability to the Quadrivalent Human Papillomavirus Virus-like Particle (VLP) Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy Compared to Healthy Children and Youth Adult Females


Inclusion Criteria:



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

Exclusion Criteria:

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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Antibody Titer to HPV 6

Outcome Time Frame:

Month 7

Safety Issue:

No

Principal Investigator

Athos Bousvaros, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Boston

Authority:

United States: Institutional Review Board

Study ID:

07-09-0344

NCT ID:

NCT00727636

Start Date:

July 2008

Completion Date:

April 2011

Related Keywords:

  • Inflammatory Bowel Disease
  • inflammatory bowel disease (IBD)
  • immunogenicity
  • safety
  • HPV
  • Gardasil
  • vaccine
  • Inflammatory Bowel Diseases
  • Intestinal Diseases

Name

Location

Children's Hospital BostonBoston, Massachusetts  02115