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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

240

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2022

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

Study Start

First participant enrolled

February 16, 2022

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2022

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed

Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

March 2, 2022

Last Update Submit

February 3, 2025

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

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
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
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
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 Outcomes (12)

Type and timing of DMT in MS patients
12 months (+3 months) from date of first dose of Covid-19 vaccine
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 Covid-19 vaccine in MS patients compared with healthy volunteers
12 months (+3 months) from date of first dose of Covid-19 vaccine
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
Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers
12 months (+3 months) from date of first dose of Covid-19 vaccine
+7 more secondary outcomes