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

NCT04837651 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2021-08-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Dragonfly Research, LLC

    lead OTHER

Principal Investigators

  • Joshua Katz, M.D. · Dragonfly Research, LLC

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2021-07-01
Completion
2021-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04837651 on ClinicalTrials.gov