Epstein-Barr Virus Antibodies in Egyptian Patients With Multiple Sclerosis

NCT07846943 | Not Yet Recruiting

• 1 other identifier: EBV Antibodies in Egyptian MS
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Multiple Sclerosis; Epstein-Barr Virus Infections; Epstein-Barr Virus (EBV) Infection

Keywords

Epstein-Barr Virus; EBV; Anti-VCA IgG; Anti-EBNA1 IgG; Expanded Disability Status Scale; EDSS; Disease-Modifying Therapies; Neuroimmunology; Demyelinating Autoimmune Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• 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.

  Baseline

Secondary Outcomes (2)

• Serum Anti-VCA IgG Antibody Titers

  Baseline

• Serum Anti-EBNA1 IgG Antibody Titers

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Multiple Sclerosis; Epstein-Barr Virus Infections; Infections

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09