NCT07636044招募中不适用
Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
The goal of this observational study is to compare the vaccine response to the 2 doses of the adjuvanted herpes zoster subunit vaccine(HZ/su, "Shingrix") in patients with SLE and the age-, sex-, ethnicity-matched controls without autoimmune disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females ≥ 50 years of age at time of consent
- •≥ 4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (14, 15)
- •Clinically stable SLE
- •Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks
- •Corticosteroid use: ≥ 5mg/day of prednisolone equivalent
- •Antimalarials (≤ 400 mg/day)
- •Azathioprine (≤ 3 mg/kg/day)
- •Mycophenolate mofetil (≤ 3 mg/day)
- •Tacrolimus (≤ 5mg/day)
- •Methotrexate (≤ 20mg/week)
- •Cyclosphosphamide (≤ 1mg/BSA/month)
- •Must be eligible for the indication of adjuvanted herpes zoster subunit vaccine
- •Must understand and voluntarily sign an informed consent form including writing consent for data protection
排除标准
- •Pregnant or lactating females
- •Acute infection with temperature >38C at the time of vaccination
- •Previous anaphylactic response to vaccine components or to egg
- •History of Guillain-Barre syndrome or demyelinating syndromes
- •Any condition including laboratory abnormality which places the subject at unacceptable risk
- •Subjects who decline to participate
研究者
Eun Bong Lee
Professor
Seoul National University Hospital
研究点 (1)
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