Covid-19 Vaccine Immune Response in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-16

Study Completion Date

2025-12-30

Brief Summary

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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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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group - Ocrelizumab

30 patients with multiple sclerosis on Ocrelizumab (standard of care)

Blood Test 1

Intervention Type 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

Blood Test 2

Intervention Type 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

Study group - Natalizumab

30 patients with multiple sclerosis on Natalizumab (standard of care)

Blood Test 1

Intervention Type 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

Blood Test 2

Intervention Type 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

Study group - Alemtuzumab

30 patients with multiple sclerosis on Alemtuzumab (standard of care)

Blood Test 1

Intervention Type 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

Blood Test 2

Intervention Type 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

Study group - Tecfidera

30 patients with multiple sclerosis on Tecfidera (standard of care)

Blood Test 1

Intervention Type 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

Blood Test 2

Intervention Type 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

Study group - Fingolimod

30 patients with multiple sclerosis on Fingolimod (standard of care)

Blood Test 1

Intervention Type 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

Blood Test 2

Intervention Type 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

Study group - Interferon

30 patients with multiple sclerosis on Interferon (standard of care)

Blood Test 1

Intervention Type 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

Blood Test 2

Intervention Type 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

Study group - off DMT

30 patients with multiple sclerosis off disease modification treatment (DMT) (standard of care)

Blood Test 1

Intervention Type 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

Blood Test 2

Intervention Type 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

Control group

30 healthy volunteers

Blood Test 1

Intervention Type 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

Blood Test 2

Intervention Type 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

Interventions

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Blood 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

Intervention Type OTHER

Blood 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Exclusion Criteria

* 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

* Has declined or does not wish to have Covid-19 vaccine
* Has MS or another long-term immunological condition
* History of taking any immune treatment causing immune suppression in the last 5 years
* History of any immune conditions or comorbidities known to result in immune suppression within the last 5 years;
* Ineligible\* for Covid-19 vaccine (\*Ineligible for health reasons and/or as per Government prioritisation of vaccinations)
* Currently participating in one or more interventional trials involving immune suppression or immune agent
* Non-English speaker where translation facilities are insufficient to guarantee informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes