NCT04748939尚未招募4 期
Safety and Immunogenicity of a Recombinant Subunit Herpes Zoster Vaccine in Patients With Rheumatic Diseases Undergoing Immunosuppressive or Biologic/Targeted DMARD Therapies: a Double-blind Randomized Placebo-controlled Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- humoral immune response to Shingrix
研究概览
简要总结
A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies
详细描述
A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies.
Duration of study: 60 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blind for the identity of the drugs
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
humoral immune response to Shingrix
时间窗: week 12 (compared with baseline)
proportion of patients with 4x fold increase in anti-gE antibody titer
次要结局
- flares of underlying diseases(week 26 and 60)
- herpes zoster infection(week 60)
- Humoral immune response(week 52)
- cell mediated response to vaccine(week 12 from baseline)
- adverse events(4 weeks after injection)
研究者
研究点 (1)
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