Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab (OCR-VAX)

Dragonfly Research

Status

Completed

Conditions

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Multiple Sclerosis

Immune System Diseases

Nervous System Diseases

Pathologic Processes

Demyelinating Diseases

Autoimmune Diseases

Treatments

Device: T-Detect COVID T-cell blood test

Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test

Study type

Observational

Funder types

Other

Identifiers

NCT04837651

VA26843

Details and patient eligibility

About

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.

Full description

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.

Enrollment

48 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

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