Immunogenicity of the Recombinant Zoster Vaccine (Shingrix ®) in Multiple Sclerosis Patients Treated With Anti-CD20 Antibodies Compared to Controls- a Phase IV Monocentric Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Geometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG
研究概览
简要总结
The purpose of this study is to provide evidence as to whether RZV is immunogenic with an acceptable safety profile in Multiple Sclerosis patients on anti-CD20 treatment.
详细描述
In this monocentric study, we will assess the immunogenicity and safety of two doses of the adjuvanted recombinant Zoster vaccine (RZV, or Shingrix®) in Multiple sclerosis patients treated with anti-CD20 (ocrelizumab, group 1) compared to healthy controls (group 2).
Participants will receive Shingrix® on Day0 and Day60; immunological response will be assessed on Day 0, 1, Day 60, 61, Day90 and Day360.
Unsolicited Adverse events of special interest (AESI) will be collected throughout the study period; patients reported outcomes (PROs) will be declared for one week after each vaccination. Safety of MS patients will be monitored through EDSS scoring and MRI before and 1 month after vaccination (D90) and at day 180 and 360 (EDSS scoring only)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For MS patients:
- •18 years and above
- •Diagnosed with relapsing MS according to McDonald Criteria (2017)
- •Not already vaccinated by RZV and willing to be vaccinated with RZV.
- •At least 1 year on anti-CD20 treatment: 2 initial infusions of Ocrelizumab 300 mg (2 weeks apart), one infusion of Ocrelizumab 600 mg 6 months apart, one infusion of Ocrelizumab 600 mg 12 months after initial infusions
- •Informed consent as documented by signature
- •For healthy controls
- •Aged 50 to 59
- •Not already vaccinated by RZV and willing to be vaccinated with RZV
- •Informed consent as documented by signature
排除标准
- •Recent MS relapse in the 6 weeks preceding planned vaccination
- •Ongoing signs of febrile or non-febrile infection at the time of vaccination
- •Recent pregnancy with delivery in the six months preceding vaccination and/or planned pregnancy in the six months following RZV vaccination
- •Immunosuppression from the following: HIV infection, current active systemic auto-immune disease (other than MS), current malignant neoplasm; primary immunodeficiency; recent solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy; conditions requiring medication with immunosuppressive drugs
- •Having received a vaccine in the last month
- •Having received a shingles vaccine within one year
- •Presented with herpes zoster in the previous year
- •Contra-indication to RZV
- •Unable to provide informed consent or inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia.
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
结局指标
主要结局
Geometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG
时间窗: day 90
gE-specific total Immunoglobulin(Ig)G titers is determined by gE-specific ELISA from sera samples
次要结局
- Vaccine safety -pIMDs(day 360)
- Vaccine safety - AESI 7 days(7 days)
- Vaccine safety - SAE 360 days(day 360)
- Vaccine safety-relapse in MS patients(day 90)
- Vaccine immunogenicity - CD4+ T cells per million of T cells, measured at D90(Day 90)
研究者
Prof Patrice Lalive
Professor
University Hospital, Geneva