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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05197699

Enrollment

160

Registered

2022-01-19

Start date

2021-07-01

Completion date

2023-09-30

Last updated

2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis (MS)

Keywords

SARS-Cov2 vaccination

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination	30 days after the last vaccination

Secondary

Measure	Time frame	Description
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 per Vaccination Cycle	Up to 33 months	—
Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle	Up to 33 months	—
Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination	6 months after 2nd vaccination	—
Number of Participants with the Tolerability to the Applied Vaccine According to the Predefined Categories	Up to 33 months	Predefined categories for assessing tolerability are tolerated better than expected, as expected, and worse than expected.
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	—

Countries

Germany

Outcome results