Covid-19 Vaccine Immune Response in Multiple Sclerosis

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: Blood Test 1; Other: Blood Test 2

• Registration Number: NCT05269888
• Lead Sponsor: University Hospitals of North Midlands NHS Trust

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-16
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-08
• Primary Completion: 2024-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group - Ocrelizumab	Blood Test 1	30 patients with multiple sclerosis on Ocrelizumab (standard of care)
Study group - Ocrelizumab	Blood Test 2	30 patients with multiple sclerosis on Ocrelizumab (standard of care)
Study group - Alemtuzumab	Blood Test 1	30 patients with multiple sclerosis on Alemtuzumab (standard of care)
Study group - Alemtuzumab	Blood Test 2	30 patients with multiple sclerosis on Alemtuzumab (standard of care)
Study group - Interferon	Blood Test 1	30 patients with multiple sclerosis on Interferon (standard of care)
Study group - Interferon	Blood Test 2	30 patients with multiple sclerosis on Interferon (standard of care)
Study group - Tecfidera	Blood Test 1	30 patients with multiple sclerosis on Tecfidera (standard of care)
Study group - Fingolimod	Blood Test 1	30 patients with multiple sclerosis on Fingolimod (standard of care)
Study group - Natalizumab	Blood Test 1	30 patients with multiple sclerosis on Natalizumab (standard of care)
Study group - Natalizumab	Blood Test 2	30 patients with multiple sclerosis on Natalizumab (standard of care)
Study group - Tecfidera	Blood Test 2	30 patients with multiple sclerosis on Tecfidera (standard of care)
Study group - off DMT	Blood Test 1	30 patients with multiple sclerosis off disease modification treatment (DMT) (standard of care)
Study group - Fingolimod	Blood Test 2	30 patients with multiple sclerosis on Fingolimod (standard of care)
Control group	Blood Test 2	30 healthy volunteers
Control group	Blood Test 1	30 healthy volunteers
Study group - off DMT	Blood Test 2	30 patients with multiple sclerosis off disease modification treatment (DMT) (standard of care)

Primary Outcome Measures

Name	Time	Method
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	12 months (+3 months) from date of first dose of Covid-19 vaccine	Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche
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	18 months (+3 months) from date of first dose of Covid-19 vaccine	Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche
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	12 months (+3 months) from date of first dose of Covid-19 vaccine	T-SPOT® COVID SARS-CoV-2 test status
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	18 months (+3 months) from date of first dose of Covid-19 vaccine	T-SPOT® COVID SARS-CoV-2 test status

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals of North Midlands NHS Trust; 🇬🇧 Stoke-on-Trent, United Kingdom