NCT06001606招募中3 期
Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus: a Randomized Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Frequency of positive humoral vaccine response at 1 month post-dose 2
研究概览
简要总结
To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥ 19 years of age at time of consent
- •≥4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (13, 14)
- •Clinically stable SLE
- •Corticosteroid use: ≥ 5mg/day of prednisolone equivalent
- •Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks
- •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 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 T >38°C 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
研究组 & 干预措施
Shingrix
Experimental
干预措施: Shingrix (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of positive humoral vaccine response at 1 month post-dose 2
时间窗: 3 months
Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration
次要结局
- Anti-gE antibody concentration at 6 months post-dose 2(8 months)
- Anti-gE antibody concentration at 12 months post-dose 2(14 months)
- Frequency of humoral responses 12 month post-dose 2(14 month)
- Frequency of positive humoral vaccine response at 6 months post-dose 2(8 months)
研究者
研究点 (1)
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