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临床试验/NCT05121662
NCT05121662已完成不适用

Immunogenicity of COVID-19 Vaccines in MS Patients on B-cell Depleting Therapy

Columbia University1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2021年7月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
1
主要终点
Level of Receptor Binding Domain (RBD)

研究概览

简要总结

SARS CoV-2 is the virus responsible for the pandemic COVID-19, which has resulted in nearly five million deaths worldwide since its spread in the beginning of 2020. In the United States, there are now two emergency use authorized vaccines that make use of messenger ribonucleic acid (mRNA) based technology that are highly effective for preventing COVID. However, because multiple sclerosis is an autoimmune condition, many individuals with multiple sclerosis take medicines that affect the immune system. The investigators are not sure whether individuals on certain MS medications, including medications that lower a type of immune cell called B lymphocytes, will form as robust of a response to the vaccines. In this study, the investigators will be gathering more information about effectiveness of these vaccines and bloodwork that looks at antibodies and other markers of vaccine response and by asking patients about COVID-19 infections.

详细描述

SARS CoV-2 is the virus responsible for the pandemic COVID-19, which has resulted in nearly five million deaths worldwide since its spread in the beginning of 2020. In the United States, there are currently two emergency use authorized mRNA based vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Multiple sclerosis (MS) is a neurological autoimmune disease involving the central nervous system and requiring long-term immunomodulating therapy to control relapse and progression. While there are many approved medications for the treatment of MS, agents that work through B-lymphocyte depletion or sequestration are among the commonly used treatments. There is concern that individuals with low levels of circulating B-cells might not mount an effective humoral or cellular immune response after vaccination. Moreover, it remains to be understood whether, at certain timepoints within the treatment cycle, there is a greater immune response mounted while on B-cell depleting medication. Availability of such knowledge could guide counseling and management of patients on immunomodulatory therapy. Aim: To ascertain efficacy of mRNA based SARS CoV-2 vaccines in individuals with MS across the immunotherapy spectrum, via biomarker data of humoral and cellular immunity and via clinical data. Blood will be drawn for markers of immunity and sequence-based analysis before and after vaccination at predetermined time points. The investigators will document the type of immunotherapy being used at the time of vaccination. Clinical data on diagnosis of SARS-CoV2 infection will be collected at each of the prespecified timepoints.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Diagnosis of any form of multiple sclerosis based on 2017 McDonald Criteria
  • Ages 18 to 70
  • No history of prior vaccination against SARS-CoV-2 at the start of the study

排除标准

  • Unable to obtain blood draws at predetermined time points
  • Pregnant at time of enrollment or planning pregnancy during upcoming 6 month period after vaccination

结局指标

主要结局

Level of Receptor Binding Domain (RBD)

时间窗: Up to 24 months

Level of RBD binding Immunoglobulin G (IgG) in blood samples

次要结局

  • Level of SARS-CoV-2 Neutralizing Antibodies(Up to 24 months)
  • T-Cell Profile(Up to 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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