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
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
- •for patients:
- •Patients with a diagnosis of rheumatic or immune-mediated diseases eg. SLE, RA, PSA, SpA, inflammatory myopathies, ANCA-related and large vessel vasculitides
- •Age ≥18 years
- •Stable or reducing doses of any the following immunosuppressive regimens within 4 weeks of study entry:
- •Prednisolone ≥20mg/kg/day ± mycophenolate mofetil, azathioprine or the calcineurin inhibitors
- •Cyclophosphamide (intravenous pulses or daily oral)
- •B-cell depleting biological agents and their biosimilars eg. belimumab, anti-CD20 agents (next scheduled dose should be arranged to at least 12 weeks after study entry for rituximab or obinutuzumab)
- •Anti-TNFα biological agents and their biosimilars eg. infliximab, etanercept, adalimumab, golimumab, certolizumab
- •Anti-interleukin-6 biological agents eg. tocilizumab, sarilumab
- •Other biological agents eg. abatacept, ustekinumab, secukinumab, ixekizumab
- •The JAK inhibitors eg. tofacitinib, baricitinib, upadacitinib
- •Female patients with reproductive potential are allowed to participate in this study provided that they are willing to practice contraception for until at least 12 months after vaccination
- •Willing to comply with all study procedures
排除标准
- •for patients:
- •Active infection, including upper respiratory tract infection
- •Active HZ infection
- •Active untreated tuberculosis
- •HIV infection
- •History of HZ or varicella vaccination in the past
- •History of allergy to any vaccines
- •Patients who are pregnant or plan to become pregnancy within one year of study entry
- •Lactating women
- •Patients who cannot give a written consent (mentally incapable or illiterate)
研究组 & 干预措施
vaccine
Shingrix vaccine
干预措施: recombinant subunit herpes zoster vaccine (Biological)
placebo
normal saline injection (0.5mL)
干预措施: recombinant subunit herpes zoster vaccine (Biological)
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
- adverse events(4 weeks after injection)
- herpes zoster infection(week 60)
- Humoral immune response(week 52)
- flares of underlying diseases(week 26 and 60)
- cell mediated response to vaccine(week 12 from baseline)
- adverse events(7 days after injection)