Clinical trial NCT05121662: COVID-19 Vaccine Biomarker Study in Multiple Sclerosis
Official title: Immunogenicity of COVID-19 Vaccines in MS Patients on B-cell Depleting Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
COVID-19
Keywords: Vaccine
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2021-11-16
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of Receptor Binding Domain (RBD)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Level of SARS-CoV-2 Neutralizing Antibodies
timeFrame: Up to 24 months
measure: T-Cell Profile
timeFrame: Up to 24 months
Other outcomes:
measure: Difference in Rates of Symptomatic COVID-19 Infection
timeFrame: Up to 24 Months
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Strauss Farber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Sarah Wesley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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