CompletedNot Applicable

COVID-19 Vaccine Response in Treated MS Patients

United States159 participantsStarted 2021-06-01

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Diagnosis of MS
✓. 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
✓. SARS-CoV2 vaccine regimen complete within the past 2-3 or 5-6 months (either Moderna® or Pfizer-BioNTech® mRNA vaccines)
✓. Age 18-65, inclusive

Exclusion criteria

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

What they're measuring

Primary endpoint

Timeframe: 11-12 months

Trial details

NCT IDNCT05060354

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-15

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