An observational study in Multiple Sclerosis, Epstein-Barr Virus Infections and Epstein-Barr Virus (EBV) Infection, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Assiut University · Observational
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).
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.
Exclusion Criteria:
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.
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.
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
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
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
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
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Assiut University