University Hospitals Cleveland Medical Center
Nora G. Singer
The purpose of this research study is to see if patients with juvenile idiopathic arthritis or seronegative arthritis (and related conditions) mount protective immune responses to the human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for any increase in disease activity following receipt of the vaccine.
Arthritis
Blood Draws for Serum Titers
Phase 4
Each individual subject's participation is scheduled to last approximately two years. Patients will be given Gardasil injections at months 0, 2, and 6. Patients will have geometric mean titers (GMT) measured at 7, 12, and 24 months. Questionnaires about health and function will also be completed at each visit.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 43 participants |
| Masking : | Single |
| Masking Description : | The geometric mean titers are analyzed in a de-identified manner at Merck Contract laboratories. |
| Primary Purpose : | Other |
| Official Title : | Pilot Study of the Safety and Efficacy of Quadrivalent Human Papillomavirus Vaccine (Gardasil®) in Female Subjects With Juvenile Idiopathic Arthritis (JIA)/ Seronegative Arthritis |
| Actual Study Start Date : | November 2007 |
| Estimated Primary Completion Date : | December 11, 2020 |
| Estimated Study Completion Date : | December 11, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Other: Group A pauciarticular JIA Females age 9-26 with pauciarticular JIA. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titres taken to measure antibody and RNA titers. |
Other: Blood Draws for Serum Titers |
|
Other: Group B polyarticular JIA Females age 9-26 with polyarticular JIA. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for Serum Titers taken to measure antibody and RNA titers. |
Other: Blood Draws for Serum Titers |
|
Other: Group C seronegative arthritis Females age 9-26 with seronegative arthritis (including ankylosing spondylitis and psoriatic arthritis). All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. |
Other: Blood Draws for Serum Titers |
| Ages Eligible for Study: | 9 Years to 26 Years |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
University of Chicago
Chicago, Illinois, United States, 60637
Not yet recruiting
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Not yet recruiting
MetroHealth
Cleveland, Ohio, United States, 44109
Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, United States, 44195