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

Sponsor
Biogen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05197699
Collaborator
(none)
200
Enrollment
12
Locations
29
Anticipated Duration (Months)
16.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination [30 days after the last vaccination]

    Secondary Outcome Measures

    1. Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination [6 months after 2nd vaccination]

    2. Change From Baseline in SARS-CoV-2 Spike Immunoglobulin A (IgA) Levels [Baseline up to 6 months after 2nd vaccination]

    3. Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels [Baseline up to 6 months after 2nd vaccination]

    4. Change From Baseline in SARS-CoV-2-Nucleocapsid Protein (NCP) IgG Levels [Baseline up to 6 months after 2nd vaccination]

    5. 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]

    6. Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle [Up to 30 months]

    7. Number of Participants per Vaccination Cycle [Up to 30 months]

    8. Number of Participants with the Tolerability to the Applied Vaccine According to the Predefined Categories [Up to 30 months]

      Predefined categories for assessing tolerability are tolerated better than expected, as expected, and worse than expected.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Multiple Sklerose Zentrum Bamberg Germany
    2 St. Josef Hospital, Klinikum der Ruhr-Universität Bochum Bochum Germany
    3 Universitätsklinikum Erlangen, Neurologische Klinik Erlangen Germany
    4 Universitätsklinik Freiburg, Neurologie Freiburg Germany
    5 Klinik für Neurologie Haar Germany
    6 UKE Hamburg, Klinik und Poliklinik für Neurologie Hamburg Germany
    7 Univ.-Klinikum Heidelberg, Neurologische Klinik Heidelberg Germany
    8 Klinik und Poliklinik für Neurologie Leipzig Germany
    9 Klinik und Poliklinik für Neurologie Munich Germany
    10 Universitätsklinikum Tübingen, Neurologie Tübingen Germany
    11 Neuropraxis München Süd Unterhaching Germany
    12 DKD Helios Klinik, Neurologie Wiesbaden Germany

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT05197699
    Other Study ID Numbers:
    • DE-MSG-11922
    First Posted:
    Jan 19, 2022
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biogen
    SARS-Cov2 vaccination
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Jan 19, 2022