Status:
ACTIVE_NOT_RECRUITING
Covid-19 Vaccine Immune Response in Multiple Sclerosis
Lead Sponsor:
University Hospitals of North Midlands NHS Trust
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief 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 pe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05269888
Start Date
February 16 2022
End Date
December 30 2025
Last Update
February 4 2025
Active Locations (1)
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1
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom, St4 6QG