Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy (HPV)
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|ClinicalTrials.gov Identifier: NCT00727636|
Recruitment Status : Completed
First Posted : August 4, 2008
Results First Posted : May 27, 2011
Last Update Posted : May 27, 2011
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||Phase|
|Inflammatory Bowel Disease||Biological: Gardasil vaccine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||April 2011|
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
- 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)
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
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Athos Bousvaros, MD||Boston Children's Hospital|
|Principal Investigator:||Denise L Jacobson, PhD, MPH||Harvard School of Public Health|