Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab
NCT04837651 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48
Last updated 2021-08-02
Summary
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.
Conditions
- Multiple Sclerosis
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Nervous System Diseases
- Demyelinating Diseases
- Autoimmune Diseases
- Immune System Diseases
- Pathologic Processes
Interventions
- DEVICE
-
Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test
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.
- DEVICE
-
T-Detect COVID T-cell blood test
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.
Sponsors & Collaborators
-
Dragonfly Research, LLC
lead OTHER
Principal Investigators
-
Joshua Katz, M.D. · Dragonfly Research, LLC
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-03-02
- Primary Completion
- 2021-07-01
- Completion
- 2021-07-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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