A Multicenter, Prospective Cohort Study to Document the Immunization Status of MS Patients in Germany With Focus on Anti-SARS-CoV-2 Vaccination Response
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 160
- 试验地点
- 12
- 主要终点
- Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination
研究概览
简要总结
The primary objective of this study is to document immunization status of MS participants after SARS-CoV-2-vaccinations and to evaluate possible effects of disease modifying therapy (DMTs) on the immune status. The secondary objectives of the study are to document longevity of immunization status of MS participants after SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to assess anti SARS-CoV-2 antibody titers regarding amount and persistence, to document immunization status of MS participants after repeated SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to document vaccine types used in MS population in Germany and to describe tolerability of SARS-CoV-2 vaccines according to participant's assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of MS according to McDonald criteria (2018)
- •SARS-CoV-2 vaccination is planned (within the upcoming 90 days), underway (only one of two vaccinations received) or only recently completed (in the last 6 weeks) or SARS-CoV-2 vaccination has been completed >6 weeks but an additional vaccination is planned within the upcoming 30 days
排除标准
- •Participant cannot be regularly followed up for organizational or geographic reasons
- •Participant is unwilling to get vaccinated against SARS CoV-2 virus
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination
时间窗: 30 days after the last vaccination
次要结局
- Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels(Baseline up to 6 months after 2nd vaccination)
- Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination(6 months after 2nd vaccination)
- Number of Participants who Developed an Immune Response to Their SARS-CoV-2-Vaccination(28 days after 2nd vaccination and 6 months after 2nd vaccination)
- Number of Participants with the Tolerability to the Applied Vaccine According to the Predefined Categories(Up to 33 months)
- Change From Baseline in SARS-CoV-2 Spike Immunoglobulin A (IgA) Levels(Baseline up to 6 months after 2nd vaccination)
- Change From Baseline in SARS-CoV-2-Nucleocapsid Protein (NCP) IgG Levels(Baseline up to 6 months after 2nd vaccination)
- Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle(Up to 33 months)
- Number of Participants per Vaccination Cycle(Up to 33 months)