Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

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.
    


Intervention name(s): Gardasil vaccine
Intervention type(s): Biological
Intervention description(s): standard 0.5 mL dose of Gardasil vaccine given at Day 0, Month 2, and Month 6
Other intervention name(s): Gardasil, HPV vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: inflammatory bowel disease (IBD); immunogenicity; safety; HPV; Gardasil; vaccine