NCT05269888Active, not recruiting
Covid-19 Vaccine Immune Response in Multiple Sclerosis
An Observational Study to Evaluate Immune Response to Covid-19 Vaccines, Infections and Immune Treatments in People With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 4 Feb 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 2 Mar 2022
- Start date
- 16 Feb 2022
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Diseases
- Multiple sclerosis
- NCT number
- NCT05269888
What you commit to
- Study type: Observational
- Planned participants: 240
- From 16 Feb 2022 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- 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)
Other
- Non-English speaker where translation facilities are insufficient to guarantee informed consent
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals of North Midlands NHS Trust Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.