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Completed

NCT Number: NCT04837651

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases COVID-19 Central Nervous System Diseases Coronaviridae Infections Coronavirus Infections Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Infections Leukoencephalopathies Lung Diseases Nervous System Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dragonfly Research, LLC

Wellesley, Massachusetts, 02481, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dragonfly Research, LLC

Other

Registry information

Official study 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

Acronym: OCR-VAX

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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