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

Multiple Sclerosis Clinical Trial

— OCR-VAX  

Official title:

A Real World, Prospective, Single-center, Observational Study Comparing Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab or Natalizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04837651
• Other study ID #: VA26843
• Status: Completed
• Start date: March 2, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: Dragonfly Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoimmune Diseases of the Nervous System
• Demyelinating Autoimmune Diseases, CNS
• Demyelinating Diseases
• Immune System Diseases
• Multiple Sclerosis
• Nervous System Diseases
• Pathologic Processes
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Dragonfly Research, LLC	Wellesley	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dragonfly Research, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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