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Comparing the Antibody Response to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab or Natalizumab (OCR-VAX)

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ClinicalTrials.gov Identifier: NCT04837651
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Dragonfly Research, LLC

Brief Summary:
The primary goal of this study is to determine if subjects currently receiving treatment with ocrelizumab or natalizumab produce antibodies to the SARS-CoV-2 spike protein receptor binding domain following immunization with the COVID-19 vaccine.

Condition or disease Intervention/treatment
Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test Device: T-Detect COVID T-cell blood test

Detailed Description:

The purpose of this study is to see if patients on ocrelizumab (Ocrevus) make antibodies in 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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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Real World, Prospective, Single-center, Observational Study Comparing the Antibody Response to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab or Natalizumab
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : March 8, 2022
Estimated Study Completion Date : September 8, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ocrelizumab Treated Multiple Sclerosis Patients 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.

Natalizumab Treated Multiple Sclerosis Patients 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.




Primary Outcome Measures :
  1. SARS-CoV-2 Antibody Production [ Time Frame: Measured within 3-4 weeks of final COVID-19 vaccine dose ]
    Production of SARS-CoV-2 antibodies in response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab.


Secondary Outcome Measures :
  1. Degree of SARS-CoV-2 Antibody Response as measured by Elecsys semi-quantitative SARS-CoV-2 antibody test (reported in U/mL) [ Time Frame: Measured within 3-4 weeks of final COVID-19 vaccine dose ]
    Difference in the degree of anti-SARS-CoV-2 antibody response (reported in U/mL by the Elecsys semi-quantitative SARS-CoV-2 antibody test) in natalizumab treated patients vs. ocrelizumab treated patients

  2. SARS-CoV-2 Vaccine Related Reactions as assessed via questionnaire one week after vaccination [ Time Frame: Measured within 1 week of vaccine dose ]
    Difference in type and severity of COVID-19 vaccine related reactions in patients currently receiving ocrelizumab or natalizumab.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult Multiple Sclerosis patients receiving treatment with natalizumab or ocrelizumab at the Elliot Lewis MS Center.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837651


Contacts
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Contact: Joshua Katz, M.D. 7815918304 JoshuaKatz@ElliotLewisMS.org
Contact: Andrew Bouley, M.D. 7815918300 andrewbouley@elliotlewisMS.org

Locations
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United States, Massachusetts
Dragonfly Research, LLC Recruiting
Wellesley, Massachusetts, United States, 02481
Contact: Joshua Katz, M.D.    781-591-8304    JoshuaKatz@ElliotLewisMS.org   
Contact: Rose-Marie Jungquist, B.S.    781-591-8313    rosiejungquist@elliotlewisMS.org   
Principal Investigator: Joshua Katz, M.D.         
Sub-Investigator: Ellen Lathi, M.D.         
Sub-Investigator: Andrew Bouley, M.D.         
Sponsors and Collaborators
Dragonfly Research, LLC
Investigators
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Principal Investigator: Joshua Katz, M.D. Dragonfly Research, LLC
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Responsible Party: Dragonfly Research, LLC
ClinicalTrials.gov Identifier: NCT04837651    
Other Study ID Numbers: VA26843
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Dragonfly Research, LLC:
COVID-19
Natalizumab
Ocrelizumab
Ocrevus
Tysabri
Antibody
Coronavirus
Vaccine
Additional relevant MeSH terms:
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Multiple Sclerosis
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases
Immune System Diseases
Sclerosis
Pathologic Processes
Leukoencephalopathies
Brain Diseases
Central Nervous System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs