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临床试验/NCT02275741
NCT02275741已完成不适用

Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis

Dr. med. Micha Loebermann1 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2009年10月最近更新:
适应症

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

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

发起方
Dr. med. Micha Loebermann
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. med. Micha Loebermann

Deputy Head, Department of Tropical Medicine an Infectious Diseases

University of Rostock

研究点 (1)

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