Pilot Study of the Safety and Efficacy of Quadrivalent Human Papillomavirus Vaccine (Gardasil®) in Female Subjects With Juvenile Idiopathic Arthritis (JIA)/ Seronegative Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 8
- 主要终点
- Positive Serum GMTs at 7 Months (HPV06)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The geometric mean titers are analyzed in a de-identified manner at Merck Contract laboratories.
入排标准
- 年龄范围
- 9 Years 至 26 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and sero-negative arthritis.
排除标准
- •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.
结局指标
主要结局
Positive Serum GMTs at 7 Months (HPV06)
时间窗: 7 months
dichotomized as negative or positive
Positive Serum GMTs at 7 Months (HPV18)
时间窗: 7 months
dichotomized as negative or positive
Positive Serum GMTs at 7 Months (HPV16)
时间窗: 7 months
dichotomized as negative or positive
Positive Serum GMTs at 7 Months (HPV11)
时间窗: 7 months
dichotomized as negative or positive
次要结局
- Peds QL(2 years)
- Positive Serum GMT (HVP11)(12 months)
- Positive Serum GMT (HVP16)(12 months)
- Positive Serum GMT (HPV18)(24 months)
- Disease Flare(2 years)
- Positive Serum GMT (HVP06)(12 months)
- Positive Serum GMT (HVP18)(12 months)
- Positive Serum GMT (HPV06)(24 months)
- Positive Serum GMT (HPV11)(24 months)
- Positive Serum GMT (HPV16)(24 months)
研究者
Nora G. Singer
M.D.
MetroHealth Medical Center