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OpenTrials
Active, Not Recruiting

NCT Number: NCT05269888

Covid-19 Vaccine Immune Response in 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, St4 6QG, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Test 1

Other

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 2

Other

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

Primary outcomes

  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

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

    Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche

  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

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

    Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche

  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

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

    T-SPOT® COVID SARS-CoV-2 test status

  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

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

    T-SPOT® COVID SARS-CoV-2 test status

Secondary outcomes

  1. Type and timing of DMT in MS patients

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

    Type and timing of DMT

  2. Type and timing of DMT in MS patients

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

    Type and timing of DMT

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

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

    Type and timing of Covid-19 vaccine

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

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

    Type and timing of Covid-19 vaccine

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

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

    Participant-reported PCR positive Covid-19 infection/s

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

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

    Participant-reported PCR positive Covid-19 infection/s

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

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

    Vaccine-related serious adverse events

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

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

    Vaccine-related serious adverse events

  9. Demographics of MS patients compared with healthy volunteers

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

    Demographics

  10. Demographics of MS patients compared with healthy volunteers

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

    Demographics

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

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

    Co-morbidity status

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

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

    Co-morbidity status

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study title

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

Acronym: CoVaR-MS

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 8, 2022
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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