LONGEVITY OF IMMUNE RESPONSE TO COVID-19 VACCINE IN VACCINATED MULTIPLE SCLEROSIS PATIENTS TREATED WITH TERIFLUNOMIDE (AUBAGIO) OR ALEMTUZUMAB (LEMTRADA)
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 1-month post 2nd COVID-19 vaccine dose.
研究概览
简要总结
Phase IV, 3-armed, prospective, open-label, single-center, Israeli study, examining the response to SARS-CoV-2 vaccination in 30 teriflunomide-, 10 alemtuzumab-treated patients, and 30 age-matched (for the teriflunomide group) untreated MS patients. Treatments will be administered according to common local practice. Demographic, clinical, treatment-related and COVID-19-related data will be collected. Blood samples will be drawn for each participant at baseline (before COVID-19 vaccination), and at 1, 3, 6, (and possibly 12) months post 2nd dose of COVID-19 vaccine. Humoral, B-cell and T-cell responses will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •(1) Diagnosis of multiple sclerosis (MS) according to 2017 McDonald criteria. (2) Age >=18 years.
- •(3) Treatment with Teriflunomide for at least 6 months/or 4 to 18 months after the last course treatment with Alemtuzumab/or untreated.
- •(4) Signed written informed consent.
排除标准
- •(1) Cognitive decline that precludes understanding the study procedures.
结局指标
主要结局
Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 1-month post 2nd COVID-19 vaccine dose.
时间窗: 6 months
Detection of SARS-CoV-2 IgG antibodies in blood samples will be performed using Euroimmun (EI, Lubeck, Germany) anti-SARS-CoV-2 IgG quantitative ELISA kit based on a recombinant S1 subunit of the SARS-CoV-2 spike protein
次要结局
- Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 3 and 6 months post 2nd COVID-19 vaccination.(12months)
- SARS-COV-2 antibody titer at 1,3 and 6 months post 2nd COVID-19 vaccination.(12 months)
- SARS-COV-2 T-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination.(12 months)
- Percent of MS COVID-19 vaccinees with positive double immune response (two responses of the possible three), or positive triple immune response (IgG, T-cell and B-cell memory positive) at 6 months post 2nd COVID-19 vaccination.(6 months)
- SARS-COV-2 B-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination.(12 months)
- Percent of MS COVID-19 vaccinees with SARS-COV-2 T-cell memory positive response at 1,3 and 6 months post 2nd COVID-19 vaccination.(12 months)
- Percent of MS COVID-19 vaccinees with SARS-COV-2 B-cell memory positive response at 1,3 and 6 months post 2nd COVID-19 vaccination. Positive cut-off value will be determined as higher than 10 SFU.(6 months)
研究者
Prof. Anat Achiron
Director, Multiple Sclerosis Center
Sheba Medical Center