Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2)-Related Multiple Sclerosis (MS) Vaccination Study
- Conditions
- Multiple Sclerosis (MS)
- Registration Number
- NCT05197699
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 160
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination 30 days after the last vaccination
- Secondary Outcome Measures
Name Time Method Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels Baseline up to 6 months after 2nd vaccination Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination 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 with the Tolerability to the Applied Vaccine According to the Predefined Categories Up to 33 months Predefined categories for assessing tolerability are tolerated better than expected, as expected, and worse than expected.
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-Nucleocapsid Protein (NCP) IgG Levels Baseline up to 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
Trial Locations
- Locations (12)
Multiple Sklerose Zentrum
🇩🇪Bamberg, Germany
Universitätsklinikum Tübingen, Neurologie
🇩🇪Tübingen, Germany
St. Josef Hospital, Klinikum der Ruhr-Universität Bochum
🇩🇪Bochum, Germany
Universitätsklinikum Erlangen, Neurologische Klinik
🇩🇪Erlangen, Germany
Univ.-Klinikum Heidelberg, Neurologische Klinik
🇩🇪Heidelberg, Germany
Universitätsklinik Freiburg, Neurologie
🇩🇪Freiburg, Germany
Klinik für Neurologie
🇩🇪Haar, Germany
UKE Hamburg, Klinik und Poliklinik für Neurologie
🇩🇪Hamburg, Germany
Klinik und Poliklinik für Neurologie
🇩🇪Leipzig, Germany
Klinik und Poliklinik für Neurologie
🇩🇪Munich, Germany
Neuropraxis München Süd
🇩🇪Unterhaching, Germany
DKD Helios Klinik, Neurologie
🇩🇪Wiesbaden, Germany