Skip to main content
OpenTrials
Completed

NCT Number: NCT05121662

COVID-19 Vaccine Biomarker Study in Multiple Sclerosis

SARS CoV-2 is the virus responsible for the pandemic COVID-19, which has resulted in nearly five million deaths worldwide since its spread in the beginning of 2020. In the United States, there are now two emergency use authorized vaccines that make use of messenger ribonucleic acid (mRNA) based technology that are highly effective for preventing COVID. However, because multiple sclerosis is an autoimmune condition, many individuals with multiple sclerosis take medicines that affect the immune system. The investigators are not sure whether individuals on certain MS medications, including medications that lower a type of immune cell called B lymphocytes, will form as robust of a response to the vaccines. In this study, the investigators will be gathering more information about effectiveness of these vaccines and bloodwork that looks at antibodies and other markers of vaccine response and by asking patients about COVID-19 infections.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System COVID-19 Coronaviridae Infections Coronavirus Infections Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Infections Lung Diseases Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

SARS CoV-2 is the virus responsible for the pandemic COVID-19, which has resulted in nearly five million deaths worldwide since its spread in the beginning of 2020. In the United States, there are currently two emergency use authorized mRNA based vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Multiple sclerosis (MS) is a neurological autoimmune disease involving the central nervous system and requiring long-term immunomodulating therapy to control relapse and progression. While there are many approved medications for the treatment of MS, agents that work through B-lymphocyte depletion or sequestration are among the commonly used treatments. There is concern that individuals with low levels of circulating B-cells might not mount an effective humoral or cellular immune response after vaccination. Moreover, it remains to be understood whether, at certain timepoints within the treatment cycle, there is a greater immune response mounted while on B-cell depleting medication. Availability of such knowledge could guide counseling and management of patients on immunomodulatory therapy. Aim: To ascertain efficacy of mRNA based SARS CoV-2 vaccines in individuals with MS across the immunotherapy spectrum, via biomarker data of humoral and cellular immunity and via clinical data. Blood will be drawn for markers of immunity and sequence-based analysis before and after vaccination at predetermined time points. The investigators will document the type of immunotherapy being used at the time of vaccination. Clinical data on diagnosis of SARS-CoV2 infection will be collected at each of the prespecified timepoints.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosis of any form of multiple sclerosis based on 2017 McDonald Criteria
  • Ages 18 to 70
  • No history of prior vaccination against SARS-CoV-2 at the start of the study

Exclusion criteria

  • Unable to obtain blood draws at predetermined time points
  • Pregnant at time of enrollment or planning pregnancy during upcoming 6 month period after vaccination

Treatment and study plan

Primary outcomes

  1. Level of Receptor Binding Domain (RBD)

    Time frame: Up to 24 months

    Level of RBD binding Immunoglobulin G (IgG) in blood samples

Secondary outcomes

  1. Level of SARS-CoV-2 Neutralizing Antibodies

    Time frame: Up to 24 months

    Level of SARS-CoV-2 Neutralizing Antibodies in blood samples

  2. T-Cell Profile

    Time frame: Up to 24 months

    T-Cell Profile of blood samples

Other outcomes

  1. Difference in Rates of Symptomatic COVID-19 Infection

    Time frame: Up to 24 Months

    Difference in rates of symptomatic COVID-19 infection following vaccination with mRNA SARS-CoV-2 vaccines between individuals with MS on B-cell depleting therapy and individuals with MS on non-cell depleting therapy.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Novartis

Registry information

Official study title

Immunogenicity of COVID-19 Vaccines in MS Patients on B-cell Depleting Therapy

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2021
Registry last updated
May 12, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.