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

NCT04837651 | Completed FDA Device

• 1 other identifier: VA26843
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID-19; Natalizumab; Ocrelizumab; Ocrevus; Tysabri; Antibody; Coronavirus; Vaccine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Ocrelizumab Treated Multiple Sclerosis Patients

Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test; Device: T-Detect COVID T-cell blood test

Natalizumab Treated Multiple Sclerosis Patients

Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test; Device: T-Detect COVID T-cell blood test

Interventions

Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test DEVICE

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.

Natalizumab Treated Multiple Sclerosis Patients; Ocrelizumab Treated Multiple Sclerosis Patients

T-Detect COVID T-cell blood test DEVICE

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; Ocrelizumab Treated Multiple Sclerosis Patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult Multiple Sclerosis patients receiving treatment with natalizumab or ocrelizumab at the Elliot Lewis MS Center.

You may qualify 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 qualify 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)
• History of allergic reactions to vaccines

Sponsors & Collaborators

• Dragonfly Research, LLC: lead

Study Sites (1)

Dragonfly Research, LLC

Wellesley, Massachusetts, 02481, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joshua Katz, M.D.

  Dragonfly Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: April 8, 2021
• Study Start: March 2, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

US (1)