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

Multiple Sclerosis (MS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05197699
• Other study ID #: DE-MSG-11922
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Sclerosis

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