Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Specific antibody response to vaccination
研究概览
简要总结
The aim of this study is to determine whether prophylactic vaccines recommended are effective and safe in patients with multiple sclerosis(MS) under MS-specific therapy.
详细描述
Protective vaccines against communicable diseases are of major importance in patients with autoimmune diseases or impaired immune response. In patients with multiple sclerosis bacterial or viral infections may lead to disease progression and vaccines can protect from these infections and prevent disease progression. Fear of possible side effects of vaccines have led to a general restraint regarding vaccination of patients with MS. However, previous studies have not shown an increased risk of disease progression following Hepatitis B vaccination and even a reduced progression rate in relapsing-remitting MS after tetanus/diphtheria vaccination.
Various disease modifying treatments (DMT) are available for MS, most of these therapies lead to an impairment of the immune system affecting the immune response to vaccination. Additionally, live attenuated vaccines may lead to severe side-effects if used in patients under DMT treatment. Testing immune response after vaccination may be prudent in subjects undergoing DMT to assure vaccination success since only a limited number of studies have investigated immune response after vaccination in patients with MS undergoing DMT.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of Multiple Sclerosis
- •Age: 18 - 70 years
- •Indication for vaccination (according to public recommendation)
- •Written informed consent
排除标准
- •Current relapse of MS
- •Unstable disease
- •Contraindication for vaccination (acute infection, fever, allergy to vaccine)
- •Unable to comply with study procedures
结局指标
主要结局
Specific antibody response to vaccination
时间窗: four weeks
Serum samples are evaluated before and 4 Weeks after vaccination
次要结局
- MS relapse rate(12 months)
研究者
Dr. med. Micha Loebermann
Deputy Head, Department of Tropical Medicine an Infectious Diseases
University of Rostock
