Clinical trial NCT05269888: Covid-19 Vaccine Immune Response in Multiple Sclerosis
Official title: An Observational Study to Evaluate Immune Response to Covid-19 Vaccines, Infections and Immune Treatments in People With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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 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).


Eligibility 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

Primary outcomes:
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
timeFrame: 12 months (+3 months) from date of first dose of Covid-19 vaccine
measure: 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
timeFrame: 18 months (+3 months) from date of first dose of Covid-19 vaccine
measure: 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
timeFrame: 12 months (+3 months) from date of first dose of Covid-19 vaccine
measure: 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
timeFrame: 18 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary outcomes:
measure: Type and timing of DMT in MS patients
timeFrame: 12 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Type and timing of DMT in MS patients
timeFrame: 18 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers
timeFrame: 12 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers
timeFrame: 18 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers
timeFrame: 12 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers
timeFrame: 18 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers
timeFrame: 12 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers
timeFrame: 18 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Demographics of MS patients compared with healthy volunteers
timeFrame: 12 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Demographics of MS patients compared with healthy volunteers
timeFrame: 18 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Co-morbidity status of MS patients compared with healthy volunteers
timeFrame: 12 months (+3 months) from date of first dose of Covid-19 vaccine
measure: Co-morbidity status of MS patients compared with healthy volunteers
timeFrame: 18 months (+3 months) from date of first dose of Covid-19 vaccine
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
References: