Skip to content

COVID-19 Vaccine Biomarker Study in Multiple Sclerosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05121662
Enrollment
154
Registered
2021-11-16
Start date
2021-07-29
Completion date
2025-02-13
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Multiple Sclerosis

Keywords

Vaccine

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.

Detailed description

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.

Interventions

None listed

Sponsors

Novartis
CollaboratorINDUSTRY
Columbia University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Level of Receptor Binding Domain (RBD)Up to 24 monthsLevel of RBD binding Immunoglobulin G (IgG) in blood samples

Secondary

MeasureTime frameDescription
Level of SARS-CoV-2 Neutralizing AntibodiesUp to 24 monthsLevel of SARS-CoV-2 Neutralizing Antibodies in blood samples
T-Cell ProfileUp to 24 monthsT-Cell Profile of blood samples

Other

MeasureTime frameDescription
Difference in Rates of Symptomatic COVID-19 InfectionUp to 24 MonthsDifference 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026