Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2)-Related Multiple Sclerosis (MS) Vaccination Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to document immunization status of MS participants after SARS-CoV-2-vaccinations and to evaluate possible effects of disease modifying therapy (DMTs) on the immune status. The secondary objectives of the study are to document longevity of immunization status of MS participants after SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to assess anti SARS-CoV-2 antibody titers regarding amount and persistence, to document immunization status of MS participants after repeated SARS-Cov-2-vaccinations and to evaluate possible effects of DMTs on the immune status, to document vaccine types used in MS population in Germany and to describe tolerability of SARS-CoV-2 vaccines according to participant's assessment.

Official Title
-----------------
A Multicenter, Prospective Cohort Study to Document the Immunization Status of MS Patients in Germany With Focus on Anti-SARS-CoV-2 Vaccination Response

Conditions
-----------------
Multiple Sclerosis (MS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Diagnosis of MS according to McDonald criteria (2018) SARS-CoV-2 vaccination is planned (within the upcoming 90 days), underway (only one of two vaccinations received) or only recently completed (in the last 6 weeks) or SARS-CoV-2 vaccination has been completed >6 weeks but an additional vaccination is planned within the upcoming 30 days Key Exclusion Criteria: Participant cannot be regularly followed up for organizational or geographic reasons Participant is unwilling to get vaccinated against SARS CoV-2 virus NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DMT-Treated Participants<br>MS participants who are receiving DMTs will be enrolled. | |
| Untreated Participants<br>MS participants who are receiving no DMT treatment or receiving only symptomatic treatment will be enrolled. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination |  | 30 days after the last vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination |  | 6 months after 2nd vaccination | 
| Change From Baseline in SARS-CoV-2 Spike Immunoglobulin A (IgA) Levels |  | Baseline up to 6 months after 2nd vaccination | 
| Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels |  | Baseline up to 6 months after 2nd vaccination | 
| Change From Baseline in SARS-CoV-2-Nucleocapsid Protein (NCP) IgG Levels |  | Baseline up to 6 months after 2nd vaccination | 
| Number of Participants who Developed an Immune Response to Their SARS-CoV-2-Vaccination |  | 28 days after 2nd vaccination and 6 months after 2nd vaccination | 
| Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle |  | Up to 33 months | 
| Number of Participants per Vaccination Cycle |  | Up to 33 months | 
| Number of Participants with the Tolerability to the Applied Vaccine According to the Predefined Categories | Predefined categories for assessing tolerability are tolerated better than expected, as expected, and worse than expected. | Up to 33 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-Cov2 vaccination