NCT05121662Completed
COVID-19 Vaccine Biomarker Study in Multiple Sclerosis
Immunogenicity of COVID-19 Vaccines in MS Patients on B-cell Depleting Therapy
Source: ClinicalTrials.gov · Last updated 12 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 154 (actual)
- First submitted
- 12 Nov 2021
- Start date
- 29 Jul 2021
- Primary completion date
- 13 Feb 2025
- Lead sponsor
- Columbia University
- Diseases
- Multiple sclerosis
- NCT number
- NCT05121662
What you commit to
- Study type: Observational
- Participants enrolled: 154
- From 29 Jul 2021 to the primary completion date, 13 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Unable to obtain blood draws at predetermined time points
- Pregnant at time of enrollment or planning pregnancy during upcoming 6 month period after vaccination
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.