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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group - Ocrelizumab | 30 patients with multiple sclerosis on Ocrelizumab (standard of care) |
| |
| Study group - Natalizumab | 30 patients with multiple sclerosis on Natalizumab (standard of care) |
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| Study group - Alemtuzumab | 30 patients with multiple sclerosis on Alemtuzumab (standard of care) |
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| Study group - Tecfidera | 30 patients with multiple sclerosis on Tecfidera (standard of care) |
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| Study group - Fingolimod | 30 patients with multiple sclerosis on Fingolimod (standard of care) |
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| Study group - Interferon | 30 patients with multiple sclerosis on Interferon (standard of care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Test 1 | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche | 12 months (+3 months) from date of first dose of Covid-19 vaccine |
| 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 | Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche | 18 months (+3 months) from date of first dose of Covid-19 vaccine |
| 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 | T-SPOT® COVID SARS-CoV-2 test status | 12 months (+3 months) from date of first dose of Covid-19 vaccine |
| 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 | T-SPOT® COVID SARS-CoV-2 test status | 18 months (+3 months) from date of first dose of Covid-19 vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Type and timing of DMT in MS patients | Type and timing of DMT | 12 months (+3 months) from date of first dose of Covid-19 vaccine |
| Type and timing of DMT in MS patients | Type and timing of DMT |
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Inclusion Criteria (Study Group - MS Patients):
Exclusion Criteria (Study Group - MS Patients):
Inclusion Criteria (Control Group - Healthy Volunteers):
Exclusion Criteria (Control Group - Healthy Volunteers):
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There are two groups of participants in this study:
Multiple Sclerosis Patients (Study Group): 210 patients with multiple sclerosis, on and off disease modification treatment (DMT):
Healthy Volunteers (Control Group): 30 healthy volunteers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of North Midlands NHS Trust | Stoke-on-Trent | St4 6QG | United Kingdom |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Study group - off DMT | 30 patients with multiple sclerosis off disease modification treatment (DMT) (standard of care) |
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| Control group | 30 healthy volunteers |
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| Blood Test 2 | Other | 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 |
|
| 18 months (+3 months) from date of first dose of Covid-19 vaccine |
| Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers | Type and timing of Covid-19 vaccine | 12 months (+3 months) from date of first dose of Covid-19 vaccine |
| Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers | Type and timing of Covid-19 vaccine | 18 months (+3 months) from date of first dose of Covid-19 vaccine |
| Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers | Participant-reported PCR positive Covid-19 infection/s | 12 months (+3 months) from date of first dose of Covid-19 vaccine |
| Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers | Participant-reported PCR positive Covid-19 infection/s | 18 months (+3 months) from date of first dose of Covid-19 vaccine |
| Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers | Vaccine-related serious adverse events | 12 months (+3 months) from date of first dose of Covid-19 vaccine |
| Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers | Vaccine-related serious adverse events | 18 months (+3 months) from date of first dose of Covid-19 vaccine |
| Demographics of MS patients compared with healthy volunteers | Demographics | 12 months (+3 months) from date of first dose of Covid-19 vaccine |
| Demographics of MS patients compared with healthy volunteers | Demographics | 18 months (+3 months) from date of first dose of Covid-19 vaccine |
| Co-morbidity status of MS patients compared with healthy volunteers | Co-morbidity status | 12 months (+3 months) from date of first dose of Covid-19 vaccine |
| Co-morbidity status of MS patients compared with healthy volunteers | Co-morbidity status | 18 months (+3 months) from date of first dose of Covid-19 vaccine |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |