COVID-19 Vaccine Biomarker Study in Multiple Sclerosis

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121662
• Other study ID #: AAAT7220
• Status: Recruiting
• Start date: July 29, 2021
• Est. completion date: July 29, 2023

Study information

• Verified date: November 2021
• Source: Columbia University
• Contact: Adelle Ricci
• Phone: 12123051485
• Email: amr2347[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 29, 2023
• Est. primary completion date: July 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in Rates of Symptomatic COVID-19 Infection	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.	Up to 24 Months
Primary	Level of Receptor Binding Domain (RBD)	Level of RBD binding Immunoglobulin G (IgG) in blood samples	Up to 24 months
Secondary	Level of SARS-CoV-2 Neutralizing Antibodies	Level of SARS-CoV-2 Neutralizing Antibodies in blood samples	Up to 24 months
Secondary	T-Cell Profile	T-Cell Profile of blood samples	Up to 24 months