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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05197699
Other study ID # DE-MSG-11922
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date September 30, 2023

Study information

Verified date April 2024
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 160
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany 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
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 fu¨r Neurologie Munich
Germany Universitätsklinikum Tübingen, Neurologie Tübingen
Germany Neuropraxis München Süd Unterhaching
Germany DKD Helios Klinik, Neurologie Wiesbaden

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination 30 days after the last vaccination
Secondary Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination 6 months after 2nd vaccination
Secondary Change From Baseline in SARS-CoV-2 Spike Immunoglobulin A (IgA) Levels Baseline up to 6 months after 2nd vaccination
Secondary Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels Baseline up to 6 months after 2nd vaccination
Secondary Change From Baseline in SARS-CoV-2-Nucleocapsid Protein (NCP) IgG Levels Baseline up to 6 months after 2nd vaccination
Secondary 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
Secondary Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle Up to 33 months
Secondary Number of Participants per Vaccination Cycle Up to 33 months
Secondary 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
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