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

N/ATerminatedNCT05197699

Biogen160 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Multiple Sclerosis (MS)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

Multiple Sklerose Zentrum

Bamberg, Germany

St. Josef Hospital, Klinikum der Ruhr-Universität Bochum

Bochum, Germany

Universitätsklinikum Erlangen, Neurologische Klinik

Erlangen, Germany

Universitätsklinik Freiburg, Neurologie

Freiburg im Breisgau, Germany

Klinik für Neurologie

Haar, Germany

UKE Hamburg, Klinik und Poliklinik für Neurologie

Hamburg, Germany

Univ.-Klinikum Heidelberg, Neurologische Klinik

Heidelberg, Germany

Klinik und Poliklinik für Neurologie

Leipzig, Germany

Klinik und Poliklinik für Neurologie

Munich, Germany

Universitätsklinikum Tübingen, Neurologie

Tübingen, Germany

...and 2 more locations

Outcomes

Primary Outcomes

Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination

Time frame: 30 days after the last vaccination

Secondary Outcomes

Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination

Time frame: 6 months after 2nd vaccination

Change From Baseline in SARS-CoV-2 Spike Immunoglobulin A (IgA) Levels

Time frame: Baseline up to 6 months after 2nd vaccination

Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels

Time frame: Baseline up to 6 months after 2nd vaccination

Change From Baseline in SARS-CoV-2-Nucleocapsid Protein (NCP) IgG Levels

Time frame: Baseline up to 6 months after 2nd vaccination

Number of Participants who Developed an Immune Response to Their SARS-CoV-2-Vaccination

Time frame: 28 days after 2nd vaccination and 6 months after 2nd vaccination

Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle

Time frame: Up to 33 months

Number of Participants per Vaccination Cycle

Time frame: 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.

Time frame: Up to 33 months