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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of the Safety and Efficacy of Quadrivalent Human Papillomavirus Vaccine (Gardasil®) in Female Subjects With Juvenile Idiopathic Arthritis (JIA)/ Seronegative Arthritis

Conditions
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Arthritis

Intervention / Treatment
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* Other: Blood Draws for Serum Titers


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Open label vaccination study Gardasil vaccine (4 component).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A pauciarticular JIA<br>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<br>* All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.<br>|
| Other: Group B polyarticular JIA<br>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<br>* All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.<br>|
| Other: Group C seronegative arthritis<br>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<br>* All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum GMTs at 7 months | dichotomized as negative or positive | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease flare | increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD | 2 years | 
| Peds QL | worsening of >30% from the prior visit | 2 years | 
| Measure serum GMT | dichotomized as negative or positive | 12 months | 
| Measure serum GMT |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JIA, SEA syndrome, AS, psoriatic arthritis, HPV vaccine