Multiple Sclerosis
Conditions
Brief summary
Coronavirus (Covid-19) has affected millions of people worldwide. Vaccines to prevent Covid-19 infection have been offered to reduce the risk of infection. While these vaccines have been offered to people with multiple sclerosis (MS), they have not been tested in these individuals. It is uncertain whether people with MS will develop protective antibodies after a Covid-19 vaccination and how long these antibodies will last. The investigators are planning to study the immune response to the full course of Covid-19 vaccine in people with MS (study group) and compare this to people without MS or immune suppression (control group).
Interventions
OTHERBlood Test 1
Blood test 1 - At 12 months (+3months) from the date of 1st Covid-19 vaccine: Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche, T-SPOT® COVID SARS-CoV-2, Full Blood Count, Serum Immunoglobulins, Anti-VZV titres
OTHERBlood Test 2
Blood test 2 - At 18 months (+3months) from the date of 1st Covid-19 vaccine: Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche, T-SPOT® COVID SARS-CoV-2, Full Blood Count, Serum Immunoglobulins, Anti-VZV titres
Sponsors
University Hospitals of North Midlands NHS Trust
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(Study Group - MS Patients): * Aged 18 years and over * Diagnosis of Multiple Sclerosis as per McDonald's Criteria 2017 * Falls into one of following the Disease Modification Treatment (DMT) groups: on Ocrelizumab, on Natalizumab, on Alemtuzumab, on Tecfidera, on Fingolimod, on Interferon, not on any DMT * Has had a complete course of Covid-19 vaccination including any boosters (standard dosing: prescribed as per the UK Government guidelines) * Willing and able to give fully informed consent * Willing and able to comply with the study procedures
Exclusion criteria
(Study Group - MS Patients): * Has declined or does not wish to have Covid-19 vaccine * Has switched DMT since the date of first dose of Covid-19 vaccine * Has any other immunological condition or on immune treatment causing immune suppression * Has declined or does not wish to have Covid-19 vaccine * Ineligible\* for Covid-19 vaccine (\*Ineligible for health reasons and/or as per Government prioritisation of vaccinations) * Non-English speaker where translation facilities are insufficient to guarantee informed consent Inclusion Criteria (Control Group - Healthy Volunteers): * Aged 18 years and over * Has had a complete course of Covid-19 vaccination (standard dosing: prescribed as per the UK Government guidelines) * Willing and able to give fully informed consent * Willing and able to comply with the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood titres of Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche in MS patients compared with healthy volunteers 12 months from date of first dose of Covid-19 vaccine | 12 months (+3 months) from date of first dose of Covid-19 vaccine | Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche |
| Blood titres of Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche in MS patients compared with healthy volunteers 18 months from date of first dose of Covid-19 vaccine | 18 months (+3 months) from date of first dose of Covid-19 vaccine | Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche |
| T-SPOT® COVID SARS-CoV-2 test status in MS patients compared with healthy volunteers 12 months from date of first dose of Covid-19 vaccine | 12 months (+3 months) from date of first dose of Covid-19 vaccine | T-SPOT® COVID SARS-CoV-2 test status |
| T-SPOT® COVID SARS-CoV-2 test status in MS patients compared with healthy volunteers 18 months from date of first dose of Covid-19 vaccine | 18 months (+3 months) from date of first dose of Covid-19 vaccine | T-SPOT® COVID SARS-CoV-2 test status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographics of MS patients compared with healthy volunteers | 12 months (+3 months) from date of first dose of Covid-19 vaccine | Demographics |
| Type and timing of DMT in MS patients | 12 months (+3 months) from date of first dose of Covid-19 vaccine | Type and timing of DMT |
| Co-morbidity status of MS patients compared with healthy volunteers | 12 months (+3 months) from date of first dose of Covid-19 vaccine | Co-morbidity status |
| Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers | 12 months (+3 months) from date of first dose of Covid-19 vaccine | Type and timing of Covid-19 vaccine |
| Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers | 12 months (+3 months) from date of first dose of Covid-19 vaccine | Participant-reported PCR positive Covid-19 infection/s |
| Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers | 12 months (+3 months) from date of first dose of Covid-19 vaccine | Vaccine-related serious adverse events |
Countries
United Kingdom
Outcome results
None listed