Covid-19 Vaccine Immune Response in Multiple Sclerosis (CoVaR-MS)

University Hospitals of North Midlands NHS Trust

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Other: Blood Test 1; Other: Blood Test 2

Study type: Observational

Funder types: Other

Identifiers

NCT05269888

3200

Details and patient eligibility

About

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).

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

240 participants in 8 patient groups

Study group - Ocrelizumab

Description:

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

Treatment:

Other: Blood Test 2

Other: Blood Test 1

Study group - Natalizumab

Description:

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

Treatment:

Other: Blood Test 2

Other: Blood Test 1

Study group - Alemtuzumab

Description:

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

Treatment:

Other: Blood Test 2

Other: Blood Test 1

Study group - Tecfidera

Description:

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

Treatment:

Other: Blood Test 2

Other: Blood Test 1

Study group - Fingolimod

Description:

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

Treatment:

Other: Blood Test 2

Other: Blood Test 1

Study group - Interferon

Description:

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

Treatment:

Other: Blood Test 2

Other: Blood Test 1

Study group - off DMT

Description:

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

Treatment:

Other: Blood Test 2

Other: Blood Test 1

Control group

Description:

30 healthy volunteers

Treatment:

Other: Blood Test 2

Other: Blood Test 1