Clareo Health | Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dragonfly Research, LLC
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.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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)
