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

NCT05197699 | Terminated

• 1 other identifier: DE-MSG-11922
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 12

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.

Conditions

Multiple Sclerosis (MS)

Keywords

SARS-Cov2 vaccination

Outcome Measures

Primary Outcomes (1)

• Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination

  30 days after the last vaccination

Secondary Outcomes (8)

• Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination

  6 months after 2nd vaccination

• 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 Spike Immunoglobulin G (IgG) 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 who Developed an Immune Response to Their SARS-CoV-2-Vaccination

  28 days after 2nd vaccination and 6 months after 2nd vaccination

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Participant cannot be regularly followed up for organizational or geographic reasons
• Participant is unwilling to get vaccinated against SARS CoV-2 virus

Sponsors & Collaborators

• Biogen: lead

Study Sites (12)

Multiple Sklerose Zentrum

Bamberg, Germany

Location

St. Josef Hospital, Klinikum der Ruhr-Universität Bochum

Bochum, Germany

Location

Universitätsklinikum Erlangen, Neurologische Klinik

Erlangen, Germany

Location

Universitätsklinik Freiburg, Neurologie

Freiburg im Breisgau, Germany

Location

Klinik für Neurologie

Haar, Germany

Location

UKE Hamburg, Klinik und Poliklinik für Neurologie

Hamburg, Germany

Location

Univ.-Klinikum Heidelberg, Neurologische Klinik

Heidelberg, Germany

Location

Klinik und Poliklinik für Neurologie

Leipzig, Germany

Location

Klinik und Poliklinik für Neurologie

Munich, Germany

Location

Universitätsklinikum Tübingen, Neurologie

Tübingen, Germany

Location

Neuropraxis München Süd

Unterhaching, Germany

Location

DKD Helios Klinik, Neurologie

Wiesbaden, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 19, 2022
• Study Start: July 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (12)