Covid-19 Vaccine Immune Response in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CoVaR-MS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05269888
• Other study ID #: 3200
• Status: Active, not recruiting
• Start date: February 16, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: University Hospitals of North Midlands NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Blood Test 1
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
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

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months (+3 months) from date of first dose of Covid-19 vaccine
Primary	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	18 months (+3 months) from date of first dose of Covid-19 vaccine
Primary	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	12 months (+3 months) from date of first dose of Covid-19 vaccine
Primary	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	18 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Type and timing of DMT in MS patients	Type and timing of DMT	12 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Type and timing of DMT in MS patients	Type and timing of DMT	18 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers	Type and timing of Covid-19 vaccine	12 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers	Type and timing of Covid-19 vaccine	18 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers	Participant-reported PCR positive Covid-19 infection/s	12 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers	Participant-reported PCR positive Covid-19 infection/s	18 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers	Vaccine-related serious adverse events	12 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers	Vaccine-related serious adverse events	18 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Demographics of MS patients compared with healthy volunteers	Demographics	12 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Demographics of MS patients compared with healthy volunteers	Demographics	18 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Co-morbidity status of MS patients compared with healthy volunteers	Co-morbidity status	12 months (+3 months) from date of first dose of Covid-19 vaccine
Secondary	Co-morbidity status of MS patients compared with healthy volunteers	Co-morbidity status	18 months (+3 months) from date of first dose of Covid-19 vaccine