Multiple sclerosis Nervous System Diseases
Conditions
Interventions
This longitudinal study, with the option to retest study subjects, will examine peripheral blood and saliva samples of people with Multiple Sclerosis (pwMS) and normal control subjects. EBV viral load
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People with MS (pwMS): 1. Diagnosis of Multiple Sclerosis according to the McDonald criteria (Thompson et al. 2018) 2. Age above 18 years 3. Informed consent Normal controls (healthy volunteers): 1. Age above 18 years 2. Informed consent 3. Absent of a pre-existing autoimmune disease, for example, type diabetes mellitus, autoimmune thyroid disease, inflammatory bowel disease, psoriasis, etc
Exclusion criteria
Exclusion criteria: People with MS and healthy subjects: 1. Other pre-existing autoimmune diseases, for example, type I diabetes mellitus, autoimmune thyroid disease, inflammatory bowel disease, psoriasis, etc 2. Unable to comply with study requirements 3. Unable to give informed consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EBV viral loads in cell-free plasma, peripheral blood mononuclear cells, B-cells, memory B-cells and saliva measured using a standard EBV-specific RT-qPCR assay at time zero, 12 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. EBV genome analysis and B cell repertoire analysis using DNA extraction, library construction, targeted enrichment and sequencing at time zero, at 12 months and at 24 months? 2. Proportion of subjects with MS who generate LCLs compared to healthy control subjects measured using LCLs ex vivo in cell culture lines numbers Time points are not relevant as this is a cross-sectional biomarker study with the option of calling back the LCL+ve subjects to assess how reproducible the findings are. 3. Relative number of EBV-associated LCLs generated by pwMS on each DMT measured using LCLs ex vivo in cell culture lines numbers. Time points are not relevant as this is a cross-sectional biomarker study with the option of calling back the LCL+ve subjects to assess how reproducible the findings are. 4. Mutations, deletions and insertions in the EBV genomes from pwMS LCLs and normal controls, measured using principal component analysis as described by Palser and colleagues (Palser et al. 2015). Time points are not relevant as this is a cross-sectional biomarker study with the option of calling back the LCL+ve subjects to assess how reproducible the findings are. 5. Proportion of subjects with MS who have type 2 EBV genome compared to healthy control subjects measured using principal component analysis as described by Palser and colleagues (Palser et al. 2015) Time points are not relevant as this is a cross-sectional biomarker study with the option of calling back the LCL+ve subjects to assess how reproducible the findings are. 6. The relative number of genetic polymorphisms in the B-cell repertoire (IgG sequences) of pwMS on each DMT measured using [method] Antibody genes will be sequencing by high-throughput Illumina Miseq sequencing (using 300bp paired-end reads). Time points are not relevant as this is a cross-sectional biomarker study with the option of calling back the LCL+ve subjects to assess how reproducible the findings are. 7. EBV-specific T-cell response measured | — |
Countries
England, United Kingdom
Contacts
Public ContactAdekunle Adeyinka;Louisa Adeniran;James
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Outcome results
None listed