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

Biogen

Status

Terminated

Conditions

Multiple Sclerosis (MS)

Study type

Observational

Funder types

Industry

Identifiers

NCT05197699

DE-MSG-11922

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.