Epstein-Barr Virus Antibodies in Egyptian Patients With Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorAssiut University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 2 trial groups
Group A: Multiple Sclerosis Group
Group B: Healthy Control Group

Trial outcomes

Primary outcomes

1

Percentage of Participants With Anti-VCA IgG Seropositivity

Assessed via enzyme-linked immunosorbent assay (ELISA) based on manufacturer-recommended optical density cut-off values to determine seropositive versus seronegative status.

Time frame
Baseline
2

Percentage of Participants With Anti-EBNA1 IgG Seropositivity

Assessed via enzyme-linked immunosorbent assay (ELISA) based on manufacturer-recommended optical density cut-off values to determine seropositive versus seronegative status.

Time frame
Baseline

Secondary outcomes

1

Serum Anti-VCA IgG Antibody Titers

Quantitative or semi-quantitative antibody titer/index values of anti-viral capsid antigen (VCA) IgG determined by ELISA microplate reader optical density measurements.

Time frame
Baseline
2

Serum Anti-EBNA1 IgG Antibody Titers

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.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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