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

This study has been completed.
Sponsor:
Collaborators:
Harvard School of Public Health
Merck
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00727636
First received: July 31, 2008
Last updated: May 3, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention
Inflammatory Bowel Disease
 Biological: Gardasil vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Antibody Titer to HPV 6 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Antibody Titer to HPV 11 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Antibody Titers to HPV 16 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
    Geometric mean titer (95% CI)

  • Antibody Titer to HPV 18 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
    Geometric mean titer (95%CI)


Enrollment: 53
Study Start Date: July 2008
Study Completion Date: April 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   9 Years to 26 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727636

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

No publications provided

Responsible Party: Athos Bousvaros, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00727636     History of Changes
Other Study ID Numbers: 07-09-0344
Study First Received: July 31, 2008
Results First Received: May 3, 2011
Last Updated: May 3, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013