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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.
ClinicalTrials.gov Identifier: NCT00727636
Recruitment Status : Completed
First Posted : August 4, 2008
Results First Posted : May 27, 2011
Last Update Posted : May 27, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
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 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.


Condition or disease Intervention/treatment
Inflammatory Bowel Disease Biological: Gardasil vaccine

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : July 2008
Primary Completion Date : June 2010
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Gardasil vaccine - Prospective Study
Prospective study participants received the Gardasil vaccine during the study
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
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


Outcome Measures

Primary Outcome Measures :
  1. Antibody Titer to HPV 6 [ Time Frame: Month 7 ]
  2. Antibody Titer to HPV 11 [ Time Frame: Month 7 ]
  3. Antibody Titers to HPV 16 [ Time Frame: Month 7 ]
    Geometric mean titer (95% CI)

  4. Antibody Titer to HPV 18 [ Time Frame: Month 7 ]
    Geometric mean titer (95%CI)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

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): NCT00727636


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Harvard School of Public Health
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Athos Bousvaros, MD Boston Children’s Hospital
Principal Investigator: Denise L Jacobson, PhD, MPH Harvard School of Public Health
More Information

Responsible Party: Athos Bousvaros, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00727636     History of Changes
Other Study ID Numbers: 07-09-0344
First Posted: August 4, 2008    Key Record Dates
Results First Posted: May 27, 2011
Last Update Posted: May 27, 2011
Last Verified: May 2011

Keywords provided by Boston Children’s Hospital:
inflammatory bowel disease (IBD)
immunogenicity
safety
HPV
Gardasil
vaccine

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Vaccines
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs