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

April 16, 2024 updated by: Biogen

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

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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bamberg, Germany
        • Multiple Sklerose Zentrum
      • Bochum, Germany
        • St. Josef Hospital, Klinikum der Ruhr-Universität Bochum
      • Erlangen, Germany
        • Universitätsklinikum Erlangen, Neurologische Klinik
      • Freiburg, Germany
        • Universitätsklinik Freiburg, Neurologie
      • Haar, Germany
        • Klinik für Neurologie
      • Hamburg, Germany
        • UKE Hamburg, Klinik und Poliklinik für Neurologie
      • Heidelberg, Germany
        • Univ.-Klinikum Heidelberg, Neurologische Klinik
      • Leipzig, Germany
        • Klinik und Poliklinik fur Neurologie
      • Munich, Germany
        • Klinik und Poliklinik fur Neurologie
      • Tübingen, Germany
        • Universitätsklinikum Tübingen, Neurologie
      • Unterhaching, Germany
        • Neuropraxis München Süd
      • Wiesbaden, Germany
        • DKD Helios Klinik, Neurologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants who are receiving any type of DMTs and participants who do not receive any medicinal treatment for their MS or receive only symptomatic treatment will be enrolled.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
DMT-Treated Participants
MS participants who are receiving DMTs will be enrolled.
Untreated Participants
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
Time Frame
Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination
Time Frame: 30 days after the last 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
Time Frame: 6 months after 2nd vaccination
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
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
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
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
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
Up to 33 months
Number of Participants per Vaccination Cycle
Time Frame: Up to 33 months
Up to 33 months
Number of Participants with the Tolerability to the Applied Vaccine According to the Predefined Categories
Time Frame: Up to 33 months
Predefined categories for assessing tolerability are tolerated better than expected, as expected, and worse than expected.
Up to 33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE-MSG-11922

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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