Epstein-Barr Virus Antibodies in Egyptian Patients With Multiple Sclerosis
Frequency and Clinical Significance of Epstein-Barr Virus Antibody Titers in Egyptian Patients With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system that causes variable degrees of neurological disability. Epstein-Barr virus (EBV) has been identified as an important environmental factor implicated in the pathogenesis and progression of MS. However, the serological profile, antibody titers, and clinical relevance of EBV infection among Egyptian individuals with MS remain limited.
The primary purpose of this hospital-based observational study is to evaluate the frequency and titers of EBV-specific antibodies, specifically anti-viral capsid antigen (anti-VCA) IgG and anti-Epstein-Barr virus nuclear antigen 1 (anti-EBNA1) IgG, in Egyptian patients diagnosed with MS compared with age- and sex-matched healthy controls. The study also aims to assess whether EBV antibody levels correlate with MS disease activity, degree of neurological disability, relapse frequency, clinical subtype, brain MRI lesion burden, and response to disease-modifying therapies (DMTs).
A total of 140 participants will be enrolled at the Department of Neurology and Psychiatry, Assiut University Hospital, comprising 70 adult patients with MS diagnosed according to the 2024 McDonald criteria and 70 matched healthy controls. Participants will undergo clinical and demographic assessment, neurological disability evaluation using the Expanded Disability Status Scale (EDSS) for MS patients, and review of existing brain MRI scans. A single venous blood sample will be collected from all participants to measure anti-VCA IgG and anti-EBNA1 IgG levels using enzyme-linked immunosorbent assay (ELISA).
研究概览
地位
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study population comprises adult Egyptian patients aged 18 to 55 years diagnosed with multiple sclerosis who attend the Department of Neurology and Psychiatry at Assiut University Hospital (Assiut, Egypt), along with age- and sex-matched apparently healthy control individuals recruited from the same geographic region.
描述
Inclusion Criteria:
- Adult individuals aged 18 to 55 years.
- Confirmed diagnosis of multiple sclerosis according to the 2024 revised McDonald criteria (for the multiple sclerosis cohort).
- Apparently healthy individuals matched by age and sex with no history of neurological disorders (for the healthy control cohort).
- Ability to understand study procedures and provide written informed consent.
Exclusion Criteria:
- Individuals younger than 18 years or older than 55 years.
- Pregnancy.
- Active or chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
- Past or current history of malignancy.
- Co-existing systemic immunosuppressive or autoimmune disorders unrelated to multiple sclerosis.
- Inability or unwillingness to provide written informed consent.
学习计划
研究是如何设计的?
设计细节
- 观测模型:CASE_CONTROL
- 时间观点:CROSS_SECTIONAL
队列和干预
团体/队列 |
|---|
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Multiple Sclerosis Group
70 adult Egyptian patients aged 18-55 years diagnosed with multiple sclerosis according to the 2024 McDonald criteria. Participants will undergo clinical and neurological assessment (including Expanded Disability Status Scale [EDSS] scoring, disease duration, relapse history, and disease-modifying therapy response), review of available brain MRI scans for lesion load and distribution patterns, and venous blood sampling for serological measurement of anti-VCA IgG and anti-EBNA1 IgG antibodies using ELISA. |
|
Healthy Control Group
70 age- and sex-matched apparently healthy individuals aged 18-55 years without history of multiple sclerosis, malignancy, viral hepatitis, HIV, or other immunosuppressive disorders. Participants will undergo demographic evaluation and venous blood sampling for serological measurement of anti-VCA IgG and anti-EBNA1 IgG antibodies using ELISA to serve as a comparison cohort. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Anti-VCA IgG Seropositivity
大体时间:Baseline
|
Assessed via enzyme-linked immunosorbent assay (ELISA) based on manufacturer-recommended optical density cut-off values to determine seropositive versus seronegative status. |
Baseline
|
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Percentage of Participants With Anti-EBNA1 IgG Seropositivity
大体时间:Baseline
|
Assessed via enzyme-linked immunosorbent assay (ELISA) based on manufacturer-recommended optical density cut-off values to determine seropositive versus seronegative status. |
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum Anti-VCA IgG Antibody Titers
大体时间:Baseline
|
Quantitative or semi-quantitative antibody titer/index values of anti-viral capsid antigen (VCA) IgG determined by ELISA microplate reader optical density measurements. |
Baseline
|
|
Serum Anti-EBNA1 IgG Antibody Titers
大体时间:Baseline
|
Quantitative or semi-quantitative antibody titer/index values of anti-Epstein-Barr virus nuclear antigen 1 (EBNA1) IgG determined by ELISA microplate reader optical density measurements. |
Baseline
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- EBV Antibodies in Egyptian MS
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