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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05950308

Enrollment

Registered

2023-07-18

Start date

2022-01-05

Completion date

2022-07-14

Last updated

2023-07-18

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

Conditions

Multiple Sclerosis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percentage of participants achieving humoral response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants	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	varied up to 6 months

Countries

United States

Outcome results