Clinical trial NCT05197699: Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2)-Related Multiple Sclerosis (MS) Vaccination Study
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis (MS)
Keywords: SARS-Cov2 vaccination
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination
timeFrame: 30 days after the last vaccination
Secondary outcomes:
measure: Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination
timeFrame: 6 months after 2nd vaccination
measure: Change From Baseline in SARS-CoV-2 Spike Immunoglobulin A (IgA) Levels
timeFrame: Baseline up to 6 months after 2nd vaccination
measure: Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels
timeFrame: Baseline up to 6 months after 2nd vaccination
measure: Change From Baseline in SARS-CoV-2-Nucleocapsid Protein (NCP) IgG Levels
timeFrame: Baseline up to 6 months after 2nd vaccination
measure: Number of Participants who Developed an Immune Response to Their SARS-CoV-2-Vaccination
timeFrame: 28 days after 2nd vaccination and 6 months after 2nd vaccination
measure: Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle
timeFrame: Up to 33 months
measure: Number of Participants per Vaccination Cycle
timeFrame: Up to 33 months
measure: Number of Participants with the Tolerability to the Applied Vaccine According to the Predefined Categories
timeFrame: Up to 33 months
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Multiple Sklerose Zentrum
city: Bochum
country: Germany
facility: St. Josef Hospital, Klinikum der Ruhr-Universität Bochum
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Neurologische Klinik
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg, Neurologie
city: Haar
country: Germany
facility: Klinik für Neurologie
city: Hamburg
country: Germany
facility: UKE Hamburg, Klinik und Poliklinik für Neurologie
city: Heidelberg
country: Germany
facility: Univ.-Klinikum Heidelberg, Neurologische Klinik
city: Leipzig
country: Germany
facility: Klinik und Poliklinik für Neurologie
city: Munich
country: Germany
facility: Klinik und Poliklinik für Neurologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Neurologie
city: Unterhaching
country: Germany
facility: Neuropraxis München Süd
city: Wiesbaden
country: Germany
facility: DKD Helios Klinik, Neurologie
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: