Table 1

Inclusion and exclusion criteria

Inclusion criteriaExclusion criteria
  1. Signed informed consent form (ICF)

  2. Age 18–65 years old (inclusive) as of the date the ICF was signed

  3. Two documented COVID-19 vaccinations (Pfizer–BioNTech, Moderna or AstraZeneca)

  4. Documented anti-SARS-CoV-2-ab screening prior to and after COVID-19 vaccination

  1. Previous treatment with other B cell-modulating therapies (eg, rituximab, atacicept, belimumab or ofatumumab)

  2. Any previous treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, ciclosporin, methotrexate, total body irradiation or bone marrow transplantation

  3. Medical, psychiatric, cognitive or other conditions that compromise the patient’s ability to understand the patient information and to give informed consent

  4. Patients who received immunosuppressants for diseases other than MS or who received long-term corticosteroid treatment

  5. Patients who received systemic high-dose corticosteroid therapy or apheresis procedures within 4 weeks prior to vaccination or in-between vaccination

  6. Patients with verified infection by HIV or hepatitis C virus

  7. Patients with medical history of COVID-19 infection or positive abs to the SARS-CoV-2 spike protein and/or nucleocapsid protein at baseline

  • ab, antibody; COVID-19, Coronavirus disease 2019; MS, multiple sclerosis; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.