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COVID-19 Vaccine Response in Treated MS Patients

CompletedN/A

Sponsor: Brigham and Women's Hospital

Conditions: Multiple Sclerosis, Healthy

Interventions: Blood draw

Countries: United States

The primary goal of this study is to assess the impact of the two major disease modifying therapy (DMT) classes (B cell therapies and S1P modulators) on humoral and cell-mediated immunity to SARS- CoV-2 vaccination compared to non-MS controls. We have chosen to compare DMT-treated MS patients to non-MS controls because the pivotal vaccine studies were conducted in non-MS healthy control groups in which there is significant clinical data and validated assays for antibody responses.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

For MS Patients:

1. Diagnosis of MS
2. Treatment with one of the four DMTs (Kesimpta (ofatumumab), Ocrevus (ocrelizumab), Gilenya (fingolimod), Mayzent (siponimod)) for at least 3 months prior to first SARS-CoV2 vaccine dose
3. SARS-CoV2 vaccine regimen complete within the past 2-3 or 5-6 months (either Moderna® or Pfizer-BioNTech® mRNA vaccines)
4. Age 18-65, inclusive

For Health Controls:

1\. Age 18-65, inclusive

Exclusion Criteria:

For MS Patients:

1\. Prior known COVID-19 infection

For Health Controls:

1. Prior known COVID-19 infection
2. major autoimmune disorders or current treatment with immunosuppressive or immunomodulatory drugs

Locations (1)

Boston, Massachusetts, United States