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Multiple SclerosisCoVaR-MSNCT05269888

Covid-19 Vaccine Immune Response in Multiple Sclerosis

An observational study of Multiple Sclerosis, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
Blood Test 1 and Blood Test 2
Type of treatment
Vaccines
How many people
240 participants
Where
1 siteUnited Kingdom
Study dates
16 Feb 2022to 30 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: There are two groups of participants in this study: 1. Multiple Sclerosis Patients (Study Group): 210 patients with multiple sclerosis, on and off disease modification treatment (DMT): * 180 patients on DMT, divided as follows: 30 patients on Ocrelizumab, 30 patients on Natalizumab, 30 patients on Alemtuzumab, 30 patients on Tecfidera, 30 patients on Fingolimod, 30 patients on Interferon * 30 patients off DMT 2. Healthy Volunteers (Control Group): 30 healthy volunteers

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, St4 6QG

Other trials in United Kingdom

About this study

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

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).

Being tested
Blood Test 1, Blood Test 2
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • Blood Test 2Other

    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

Study groups in NCT05269888
Study groupRoleWhat they receive
Study group - Ocrelizumab30 patients with multiple sclerosis on Ocrelizumab (standard of care)
Receives: Other: Blood Test 1; Other: Blood Test 2
Study group - Natalizumab30 patients with multiple sclerosis on Natalizumab (standard of care)
Receives: Other: Blood Test 1; Other: Blood Test 2
Study group - Alemtuzumab30 patients with multiple sclerosis on Alemtuzumab (standard of care)
Receives: Other: Blood Test 1; Other: Blood Test 2
Study group - Tecfidera30 patients with multiple sclerosis on Tecfidera (standard of care)
Receives: Other: Blood Test 1; Other: Blood Test 2
Study group - Fingolimod30 patients with multiple sclerosis on Fingolimod (standard of care)
Receives: Other: Blood Test 1; Other: Blood Test 2
Study group - Interferon30 patients with multiple sclerosis on Interferon (standard of care)
Receives: Other: Blood Test 1; Other: Blood Test 2
Study group - off DMT30 patients with multiple sclerosis off disease modification treatment (DMT) (standard of care)
Receives: Other: Blood Test 1; Other: Blood Test 2
Control group30 healthy volunteers
Receives: Other: Blood Test 1; Other: Blood Test 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

Secondary outcomes (12)

  1. Type and timing of DMT in MS patients

    Type and timing of DMT

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

  2. Type and timing of DMT in MS patients

    Type and timing of DMT

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

  3. Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers

    Type and timing of Covid-19 vaccine

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

  4. Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers

    Type and timing of Covid-19 vaccine

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

  5. Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers

    Participant-reported PCR positive Covid-19 infection/s

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

  6. Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers

    Participant-reported PCR positive Covid-19 infection/s

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

  7. Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers

    Vaccine-related serious adverse events

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

  8. Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers

    Vaccine-related serious adverse events

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

  9. Demographics of MS patients compared with healthy volunteers

    Demographics

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

  10. Demographics of MS patients compared with healthy volunteers

    Demographics

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

  11. Co-morbidity status of MS patients compared with healthy volunteers

    Co-morbidity status

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

  12. Co-morbidity status of MS patients compared with healthy volunteers

    Co-morbidity status

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2022
  2. Study start16 Feb 2022
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05269888
Sponsor's protocol ID
3200
Acronym
CoVaR-MS
Status last verified
Feb 2025
First submitted
2 Mar 2022
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 12 months (+3 months) from date of first dose of Covid-19 vaccine). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05269888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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