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

University Hospitals (UH)

Status: Completed

Conditions: Arthritis

Treatments: Other: Blood Draws for Serum Titers

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00573651

CHASE

Gardasil in JIA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 43 patients

Sex: Female

Ages: 9 to 26 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

JIA except SJIA with active systemic symptoms

Other group

Description:

Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. 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.

Treatment:

Other: Blood Draws for Serum Titers