Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab
Completed
Conditions studied: Multiple Sclerosis, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases, Immune System Diseases, Pathologic Processes
In brief
The primary goal of this study is to provide additional data regarding B and T-cell mediated responses to COVID-19 vaccines in MS patients treated with OCR and to determine which clinical and paraclinical variables correlating with vaccine immunogenicity. B-cell mediated humoral responses and adaptive T-cell mediated cellular responses were measured in patients treated with OCR who received any of the available SARS-CoV-2 vaccines, 3-4 weeks after completion of vaccination.
Key facts
- Study ID
- NCT04837651
- Run by
- Dragonfly Research, LLC
- People needed
- 48
- Starts
- 2021-03-02
- Expected to finish
- 2021-07-01
- Last updated by the study team
- 2021-08-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 18-55
- Diagnosis of multiple sclerosis (as per the revised 2017 criteria)
- EDSS score of 0-5.5 inclusive
- Has initiated ocrelizumab or natalizumab at least 6 months prior to study enrollment
- For women of childbearing potential: agreement to remain abstinent or to use a highly effective (99% efficacy or greater) contraceptive method
- Individual must be able to provide consent, read/write/comprehend English language or must be able to provide a consistent translator
You may not qualify if…
- Previous infection with COVID-19, confirmed by FDA approved testing
- Cognitive impairment limiting the ability to consent or complete study procedures
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- Any prior use of immunosuppressive or chemotherapy treatment (including, but not limited to, cladribine, alemtuzumab, mycophenolate mofetil, cyclophosphamide, methotrexate, azathioprine)
- Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion excluding standard ocrelizumab pre-treatment therapy
- Use of systemic corticosteroid therapy within 12 weeks of screening (excluding corticosteroid treatment given concurrently with ocrelizumab)
- History of allergic reactions to vaccines
Where it is running
- Dragonfly Research, LLC — Wellesley, Massachusetts, United States
Full record on ClinicalTrials.gov
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