TerminatedN/AOther

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

Sponsored by Biogen

NCT ID
NCT05197699
Target Enrollment
160 participants
Start Date
2021-07-01
Est. Completion
2023-09-30

About This Study

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.

Conditions Studied

Multiple Sclerosis (MS)

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full 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.

Study 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

+2 more locations

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

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