Phase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Frequency of Participants With Adverse Events
研究概览
简要总结
Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18. Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with mild to moderate and minimally active or inactive SLE and measure how well they make protective antibodies after receiving the vaccine. In other words this will check how well the vaccine works in SLE.
详细描述
To gather safety information and adverse events on the use of Gardasil® in mild to moderate and minimally active or inactive SLE.
To gather information on SLE disease activity flares after vaccination with Gardasil®.
To gather information on the immunogenicity or development of protective anti HPV antibodies SLE after vaccination with Gardasil®.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of systemic lupus erythematosis (SLE) by the American College of Rheumatology (ACR) Criteria.
- •History of a positive antinuclear antibody (ANA) test result at any time in the past.
- •40 participants with history of mild to moderate SLE disease Minimally active or inactive SLE disease, i.e., (Safety of Estrogens in Lupus Erythematosis National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), SELENA-SLEDAI ≤2 at the start of the study.
- •Age ≥ 18 years and ≤ 50 years. Gender: females Ability to provide informed consent. Maintenance Prednisone dose ≤ 15 mg/day. Plaquenil ≤ 400 mg/day.
排除标准
- •Hypersensitivity to any vaccine component Active infections including but not limited to human immunodeficiency virus (HIV positive), Hepatitis B or C, tuberculosis.
- •Positive purified protein derivative (PPD) test results without evidence of prior treatment or administration of bacilli Calmette-Guerin (BCG) vaccine. A positive PPD is defined as ≥ 5 mm induration 24-38 hours after receiving 5TU (TU=tuberculin units) of PPD.
- •Pregnancy or desire to become pregnant during the study period. Breast feeding. Inability to complete the immunization series. Received any blood product or component in the previous 6 months before enrollment.
- •Received any inactivated vaccine product within 14 days before enrollment. Received any live vaccine product within 21 days before enrollment.
- •Fever (temperature > 100°F) at the time of enrollment. Inability to provided informed consent.
研究组 & 干预措施
Gardasil
0.5 ml single dose Gardasil vaccine given at three separate visits
干预措施: Gardasil (Drug)
结局指标
主要结局
Frequency of Participants With Adverse Events
时间窗: 1,61,66,181,186,211,330 days
Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,
Number of Non Vaccine Adverse Events
时间窗: 1,61,66,181,186,211,330 days
the number of non vaccine adverse events
次要结局
- Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer(Baseline (prevaccine) neutralizing anti HPV antibody titers at visit 1 and anti HPV antibody titers at 1 month post 3rd vaccine shot which is at 7 months in the study.)
- SLE Disease Activity Flares(1,61,66,181,186,211,330 days)
研究者
Patricia Dhar
Assistant Professor of Medicine
Wayne State University