An Observational Study to Evaluate Immune Response to Covid-19 Vaccines, Infections and Immune Treatments in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Blood titres of Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche in MS patients compared with healthy volunteers 12 months from date of first dose of Covid-19 vaccine
研究概览
简要总结
Coronavirus (Covid-19) has affected millions of people worldwide. Vaccines to prevent Covid-19 infection have been offered to reduce the risk of infection. While these vaccines have been offered to people with multiple sclerosis (MS), they have not been tested in these individuals. It is uncertain whether people with MS will develop protective antibodies after a Covid-19 vaccination and how long these antibodies will last.
The investigators are planning to study the immune response to the full course of Covid-19 vaccine in people with MS (study group) and compare this to people without MS or immune suppression (control group).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Blood titres of Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche in MS patients compared with healthy volunteers 12 months from date of first dose of Covid-19 vaccine
时间窗: 12 months (+3 months) from date of first dose of Covid-19 vaccine
Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche
Blood titres of Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche in MS patients compared with healthy volunteers 18 months from date of first dose of Covid-19 vaccine
时间窗: 18 months (+3 months) from date of first dose of Covid-19 vaccine
Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche
T-SPOT® COVID SARS-CoV-2 test status in MS patients compared with healthy volunteers 12 months from date of first dose of Covid-19 vaccine
时间窗: 12 months (+3 months) from date of first dose of Covid-19 vaccine
T-SPOT® COVID SARS-CoV-2 test status
T-SPOT® COVID SARS-CoV-2 test status in MS patients compared with healthy volunteers 18 months from date of first dose of Covid-19 vaccine
时间窗: 18 months (+3 months) from date of first dose of Covid-19 vaccine
T-SPOT® COVID SARS-CoV-2 test status
次要结局
- Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers(18 months (+3 months) from date of first dose of Covid-19 vaccine)
- Type and timing of DMT in MS patients(18 months (+3 months) from date of first dose of Covid-19 vaccine)
- Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers(18 months (+3 months) from date of first dose of Covid-19 vaccine)
- Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers(18 months (+3 months) from date of first dose of Covid-19 vaccine)
- Demographics of MS patients compared with healthy volunteers(18 months (+3 months) from date of first dose of Covid-19 vaccine)
- Co-morbidity status of MS patients compared with healthy volunteers(18 months (+3 months) from date of first dose of Covid-19 vaccine)