COVID-19 Vaccine Biomarker Study in Multiple Sclerosis

NCT05121662 | Completed

• 1 other identifier: AAAT7220
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; COVID-19

Keywords

Vaccine

Outcome Measures

Primary Outcomes (1)

• Level of Receptor Binding Domain (RBD)

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

  Up to 24 months

Secondary Outcomes (2)

• Level of SARS-CoV-2 Neutralizing Antibodies

  Up to 24 months

• T-Cell Profile

  Up to 24 months

Other Outcomes (1)

• Difference in Rates of Symptomatic COVID-19 Infection

  Up to 24 Months

Study Arms (1)

Individuals with Multiple Sclerosis (MS)

Individuals with MS on B-cell depleting therapy, non-cell depleting therapy, or no therapy.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with multiple sclerosis who received vaccination 50 of these subjects will be on B-cell depleting agents (ofatumumab, ocrelizumab, and rituximab) and the other 50 will either not be on immunotherapy for MS or will be on non-cell depleting therapies (glatiramer acetate, beta-interferons, natalizumab, dimethyl fumarate, diroxyl fumarate, teriflunomide, siponimod, fingolimod and ozanimod).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Novartis: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; COVID-19

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rebecca Strauss Farber, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Sarah Wesley, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 16, 2021
• Study Start: July 29, 2021
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: May 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)