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ACTIVE NOT RECRUITING

NCT05269888

Covid-19 Vaccine Immune Response in Multiple Sclerosis

Sponsor: University Hospitals of North Midlands NHS Trust

View on ClinicalTrials.gov

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).

Official title: An Observational Study to Evaluate Immune Response to Covid-19 Vaccines, Infections and Immune Treatments in People With Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

240

Start Date

2022-02-16

Completion Date

2025-12-30

Last Updated

2025-02-04

Healthy Volunteers

Yes

Conditions

Multiple Sclerosis

Interventions

OTHER

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

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

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 Exclusion Criteria (Control Group - Healthy Volunteers): * 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

Locations (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom