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

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ClinicalTrials.gov Identifier: NCT04837651
Recruitment Status : Completed
First Posted : April 8, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Dragonfly Research, LLC

Tracking Information
First Submitted Date March 16, 2021
First Posted Date April 8, 2021
Last Update Posted Date August 2, 2021
Actual Study Start Date March 2, 2021
Actual Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2021)
  • SARS-CoV-2 B-cell response [ 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.
  • SARS-CoV-2 T-cell response [ Time Frame: Measured within 3-4 weeks of final COVID-19 vaccine dose ]
    Production of SARS-CoV-2 T-cell response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab.
Original Primary Outcome Measures
 (submitted: April 7, 2021)
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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: April 7, 2021)
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab
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
Brief 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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult Multiple Sclerosis patients receiving treatment with natalizumab or ocrelizumab at the Elliot Lewis MS Center.
Condition
  • Multiple Sclerosis
  • Demyelinating Autoimmune Diseases, CNS
  • Autoimmune Diseases of the Nervous System
  • Nervous System Diseases
  • Demyelinating Diseases
  • Autoimmune Diseases
  • Immune System Diseases
  • Pathologic Processes
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.
  • 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.
Study Groups/Cohorts
  • Ocrelizumab Treated Multiple Sclerosis Patients
    Interventions:
    • Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test
    • Device: T-Detect COVID T-cell blood test
  • Natalizumab Treated Multiple Sclerosis Patients
    Interventions:
    • Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test
    • Device: T-Detect COVID T-cell blood test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 20, 2021)
48
Original Estimated Enrollment
 (submitted: April 7, 2021)
100
Actual Study Completion Date July 1, 2021
Actual Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04837651
Other Study ID Numbers VA26843
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement Not Provided
Responsible Party Dragonfly Research, LLC
Study Sponsor Dragonfly Research, LLC
Collaborators Not Provided
Investigators
Principal Investigator: Joshua Katz, M.D. Dragonfly Research, LLC
PRS Account Dragonfly Research, LLC
Verification Date July 2021