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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.
The purpose of this study is to see if patients on ocrelizumab (Ocrevus) produce a humoral and T-cell response to the coronavirus vaccine. Ocrelizumab depletes B-lymphocytes and has the potential to reduce the effectiveness of vaccines. The impact of ocrelizumab treatment on coronavirus vaccines is unknown.
Natalizumab (Tysabri) likely has a minimal impact the efficacy of vaccines. In this study the investigators will take blood samples in patients being treated with either ocrelizumab or natalizumab before and after vaccination with an FDA-authorized coronavirus (COVID-19) vaccine and compare the antibody response in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab Treated Multiple Sclerosis Patients |
| ||
| Natalizumab Treated Multiple Sclerosis Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test | Device | Subjects will receive an Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test within 4 weeks of receiving their first COVID-19 injection. Within 3-4 weeks of receipt of their final COVID-19 vaccine dose, subjects will receive another Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test. |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 B-cell response | Production of SARS-CoV-2 antibodies in response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab. | Measured within 3-4 weeks of final COVID-19 vaccine dose |
| SARS-CoV-2 T-cell response | Production of SARS-CoV-2 T-cell response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab. | Measured within 3-4 weeks of final COVID-19 vaccine dose |
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Inclusion Criteria
Exclusion Criteria
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Adult Multiple Sclerosis patients receiving treatment with natalizumab or ocrelizumab at the Elliot Lewis MS Center.
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Katz, M.D. | Dragonfly Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dragonfly Research, LLC | Wellesley | Massachusetts | 02481 | United States |
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| T-Detect COVID T-cell blood test | Device | A select number of subjects will also receive a qualitative SARS-CoV-2 t-cell immunity test, the T-Detect COVID test, within 3-4 weeks of receipt of their final COVID-19 vaccine dose. |
|
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D056784 | Leukoencephalopathies |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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