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).
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_CONTROL
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
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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. |
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants With Anti-VCA IgG Seropositivity
Délai: 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
Délai: Baseline
|
Assessed via enzyme-linked immunosorbent assay (ELISA) based on manufacturer-recommended optical density cut-off values to determine seropositive versus seronegative status. |
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serum Anti-VCA IgG Antibody Titers
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Maladies auto-immunes
- Maladies du système immunitaire
- Maladies virales
- Maladies auto-immunes démyélinisantes, SNC
- Maladies auto-immunes du système nerveux
- Maladies démyélinisantes
- Infections par le virus de l'ADN
- Infections à Herpesviridae
- Infections virales tumorales
- Sclérose en plaques
- Infections
- Infections par le virus Epstein-Barr
Autres numéros d'identification d'étude
- EBV Antibodies in Egyptian MS
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