Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Anti-HPV 6 Seroconversion
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.
详细描述
Female patients with systemic lupus erythematosus (SLE) have been found have higher rates of persistent HPV infections and precancerous lesions compared to the healthy population. The HPV vaccine Gardasil has been found to be safe and efficacious in females aged 9 to 26 years. There are no data on the immunogenicity and safety of Gardasil in females with SLE. Immune dysfunction related to SLE itself and the immunosuppression secondary to treatment of SLE might prevent patients with SLE from developing an adequate immune response to the vaccine. Also, theoretically, the vaccine might induce a disease exacerbation or production of new autoantibodies.
The purpose of this study is to evaluate immunogenicity and safety of Gardasil and its effects on autoantibody profile in female SLE patients aged 9-26 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age: 9 to 26 years of age
- •Gender: Female
- •All patients must fulfill the revised American College of Rheumatology Classification Criteria for SLE diagnosis.
- •Current SLEDAI score ≤ 6
- •Written, witnessed informed consent and/or assent will be obtained from the subject and the subject's parents (if under 18 years of age) or legally acceptable representative prior to enrollment
排除标准
- •Acute exacerbation of disease within past 30 days which required increase in corticosteroid dose, initiation of a new immunosuppressive medication, or hospitalization
- •Current SLEDAI score > 6
- •Patients who have received rituximab in the last 6 months, or are currently on cyclophosphamide treatment
- •History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine
- •Previous administration of any HPV vaccine
研究组 & 干预措施
Gardasil
30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6.
干预措施: Gardasil (Biological)
结局指标
主要结局
Anti-HPV 6 Seroconversion
时间窗: 7 months
Percent Seropositive
Anti-HPV 16 Seroconversion
时间窗: 7 months
% Seropositive
Anti-HPV 18 Seroconversion
时间窗: 7 months
% Seropositive
Anti-HPV 11 Seroconversion
时间窗: 7 months
% Seropositive
Anti-HPV 6 GMT
时间窗: 7 months
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 18 GMT
时间窗: 7 months
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 11 GMT
时间窗: 7 months
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 16 GMT
时间窗: 7 months
Geometric mean titre in milli-Merck units per ml (mMu/ml)
SLEDAI Change Score
时间窗: 7 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.
次要结局
- Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP(7 months)
- Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)(7 months)
- Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)(7 months)