Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 9 - 26 |
| Updated: | 6/9/2018 |
| Start Date: | November 2007 |
| End Date: | September 30, 2018 |
Pilot Study of the Safety and Efficacy of Quadrivalent Human Papillomavirus Vaccine (Gardasil®) in Female Subjects With Juvenile Idiopathic Arthritis (JIA)/ Seronegative Arthritis
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.
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.
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.
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.
Inclusion Criteria:
- Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and
sero-negative arthritis.
Exclusion Criteria:
- Pregnancy
- Known allergy/sensitivity or any hypersensitivity to yeast or components of study drug
or their formulation
- Systemic onset JIA with active systemic symptoms (systemic onset JIA with
polyarticular features but no fever or rash may be included).
- Prior vaccination against HPV
- Known HPV infection
- Current or history of cervical cancer or cervical intraepithelial neoplasia (CIN).
Males are excluded from this study because Gardasil® is currently approved only for
females.
We found this trial at
4
sites
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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