Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy (HPV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727636
Recruitment Status : Completed
First Posted : August 4, 2008
Results First Posted : May 27, 2011
Last Update Posted : May 27, 2011
Harvard School of Public Health
Merck Sharp & Dohme Corp.
Information provided by:
Boston Children’s Hospital

July 31, 2008
August 4, 2008
May 3, 2011
May 27, 2011
May 27, 2011
July 2008
June 2010   (Final data collection date for primary outcome measure)
  • Antibody Titer to HPV 6 [ Time Frame: Month 7 ]
  • Antibody Titer to HPV 11 [ Time Frame: Month 7 ]
  • Antibody Titers to HPV 16 [ Time Frame: Month 7 ]
    Geometric mean titer (95% CI)
  • Antibody Titer to HPV 18 [ Time Frame: Month 7 ]
    Geometric mean titer (95%CI)
antibody titer to HPV vaccine strains [ Time Frame: Day 1, Month 7 ]
Complete list of historical versions of study NCT00727636 on Archive Site
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vaccine-associated adverse events and side effects [ Time Frame: Day 1, Month 2, Month 6 ]
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Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy
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

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 response, they may need to increase the dosage or get booster shots. Many clinicians who treat patients with autoimmune diseases are asking if the vaccine is safe and effective. Thus, this study has important clinical and public health significance because more than one million people in the United States have been diagnosed with IBD.

There is not much studied about HPV and immunocompromised patients. Research on healthy women who were immunized with a set of three HPV vaccines demonstrated significantly increased antibody titers. In addition, they had significantly reduced HPV incident and persistent infection and HPV-related disease (cervical, vulvar, and vaginal cancers, cervical intraepithelial neoplasia, genital warts) through five years of follow-up compared to controls who received a placebo. The HPV vaccine was well tolerated without significant side effects.

The aims of this research are to measure the immune response in 9-26 year old IBD patients who are on immunosuppressive agents after receiving the HPV vaccine compared with historical controls. We will also evaluate the number and type of vaccine-associated adverse events as well as the disease activity and flare-ups that occur after each dose of vaccine. We hypothesize that IBD patients on immunosuppressive therapy will have have a similar immune response to HPV types 6, 11, 16 and 18 at one month postdose 3 compared to healthy age-matched historical controls.

The patient population includes IBD patients who are on immunosuppressive medications. Recruiting approximately 100 patients will provide adequate power for the study. A blood sample will be taken from all IBD patients to evaluate baseline antibody levels and markers (e.g., ESR, CBC, albumin) before or immediately after immunization with the HPV vaccine. Lab tests will be redrawn at 7 months to evaluate the level of antibody titers and follow the markers. During the study, we will track basic laboratory measures, disease status by using the Pediatric Crohn's Disease Active Index or Harvey-Bradshaw Index for UC, side effects from the vaccinations, and other adverse events.

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Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Inflammatory Bowel Disease
Biological: Gardasil vaccine
standard 0.5 mL dose of Gardasil vaccine given at Day 0, Month 2, and Month 6
Other Name: Gardasil, HPV vaccine
  • Experimental: Gardasil vaccine - Prospective Study
    Prospective study participants received the Gardasil vaccine during the study
    Intervention: Biological: Gardasil vaccine
  • No Intervention: Retrospective Study
    Retrospective study participants had blood drawn in the study after they had received the Gardasil vaccine from their primary medical provider
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2011
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
9 Years to 26 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Athos Bousvaros, MD, Children's Hospital Boston
Boston Children’s Hospital
  • Harvard School of Public Health
  • Merck Sharp & Dohme Corp.
Principal Investigator: Athos Bousvaros, MD Boston Children’s Hospital
Principal Investigator: Denise L Jacobson, PhD, MPH Harvard School of Public Health
Boston Children’s Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP