Multiple SclerosisNCT05121662
COVID-19 Vaccine Biomarker Study in Multiple Sclerosis
An observational study of Multiple Sclerosis and COVID-19, run by Columbia University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, COVID-19
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 13 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Unable to obtain blood draws at predetermined time points
- Pregnant at time of enrollment or planning pregnancy during upcoming 6 month period after vaccination
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Immunogenicity of COVID-19 Vaccines in MS Patients on B-cell Depleting Therapy
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.
Read the 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.
- Conditions
- Multiple Sclerosis, COVID-19
- Keywords
- Vaccine
- Medical subject headings
- Multiple Sclerosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Multiple Sclerosis (MS) | Individuals with MS on B-cell depleting therapy, non-cell depleting therapy, or no therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Receptor Binding Domain (RBD)
Level of RBD binding Immunoglobulin G (IgG) in blood samples
Measured: Up to 24 months
Secondary outcomes (2)
Level of SARS-CoV-2 Neutralizing Antibodies
Level of SARS-CoV-2 Neutralizing Antibodies in blood samples
Measured: Up to 24 months
T-Cell Profile
T-Cell Profile of blood samples
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start29 Jul 2021
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Rebecca Strauss Farber, MD, Principal investigator, Columbia UniversitySarah Wesley, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121662
- Sponsor's protocol ID
- AAAT7220
- Status last verified
- May 2025
- First submitted
- 12 Nov 2021
- Last updated
- 12 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of COVID-19 Vaccines in MS Patients on B-cell Depleting Therapy
- ClinicalTrials.gov ID
- NCT05121662
- Acronym / sponsor ID
- AAAT7220
- Conditions
- Multiple Sclerosis, COVID-19
- Keywords
- Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Multiple Sclerosis (MS) | – | –Individuals with MS on B-cell depleting therapy, non-cell depleting therapy, or no therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to obtain blood draws at predetermined time points
- Pregnant at time of enrollment or planning pregnancy during upcoming 6 month period after vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Receptor Binding Domain (RBD)
Time frame: Up to 24 months
Level of RBD binding Immunoglobulin G (IgG) in blood samples
2 secondary outcomes
Level of SARS-CoV-2 Neutralizing Antibodies
Time frame: Up to 24 months
T-Cell Profile
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Strauss Farber, MD principal investigator
Columbia University
Sarah Wesley, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and COVID-19, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Receptor Binding Domain (RBD) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2025.