Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies

Novartis Pharmaceuticals61 enrolled

Overview

Vaccine responses in patients treated with anti-CD20 antibodies (ocrelizumab and ofatumumab) or S1P receptor modulators (fingolimod and siponimod) were evaluated before and after third SARS-CoV-2 vaccination as part of an ongoing longitudinal study. Total spike protein and spike receptor binding domain (RBD)-specific immunoglobulin G (IgG) responses were measured by Luminex bead-based assay. Spike-specific CD4+ and CD8+ T cell responses were measured by activation-induced marker expression.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria All Participants: * Aged 18-75 years old MS Patients * Diagnosed with MS based on 2017 McDonald criteria Exclusion Criteria All Participants: * Participants with a known history of COVID-19 Healthy Adults * Immunocompromised or on immunosuppressive therapy MS Patients * None specified

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Percentage of participants achieving humoral response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants

Time frame: varied up to 6 months

Percentage of participants achieving T-cell response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants

Time frame: varied up to 6 months