Covid-19 Vaccine Immune Response in Multiple Sclerosis

N/AActive Not RecruitingNCT05269888

University Hospitals of North Midlands NHS Trust240 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Multiple Sclerosis

Interventions

Blood Test 1OTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 18 months (+3 months) from date of first dose of Covid-19 vaccine

Secondary Outcomes

Type and timing of DMT in MS patients

Type and timing of DMT

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 18 months (+3 months) from date of first dose of Covid-19 vaccine

Demographics of MS patients compared with healthy volunteers

Demographics

Time frame: 12 months (+3 months) from date of first dose of Covid-19 vaccine

Demographics of MS patients compared with healthy volunteers

Demographics

Time frame: 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

Time frame: 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

Time frame: 18 months (+3 months) from date of first dose of Covid-19 vaccine

Covid-19 Vaccine Immune Response in Multiple Sclerosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes