Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis

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.

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.

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.