NCT05286242Completed
Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
The purpose of this study is to understand the immune response to coronavirus disease-19 (COVID-19) vaccination in patients on B-cell depleting therapies (BCDT) over time, which in the future may help to inform clinical decision making in this patient population.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 196 (actual)
- First submitted
- 15 Mar 2022
- Start date
- 10 Feb 2021
- Primary completion date
- 22 May 2026
- Lead sponsor
- Yale University
- Diseases
- Multiple sclerosis
- NCT number
- NCT05286242
What you commit to
- Study type: Observational
- Participants enrolled: 196
- From 10 Feb 2021 to the primary completion date, 22 May 2026
- 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.
Prior treatment
- Anti-CD20 B-cell depleting therapy infused within 2 weeks of first study visit
Other illness
- Use of high dose steroids for treatment of neurologic/immunologic disease within 1 month of COVID-19 vaccination
Other
- Inability to comply with the requirements of the protocol, in the opinion of the primary investigator
Criteria the registry did not label
- Subjects with neurologic/immunologic condition:
- at least 18 years of age
- Known diagnosis of autoimmune neurologic disease (e.g. multiple sclerosis (MS), neuromyelitis optica, myelin oligodendrocyte glycoprotein (MOG) -associated disorder) or autoimmune blistering disease (AIBD).
- EITHER:
- Treated with an anti-CD20 (rituximab, ocrelizumab) medications for \>6 months at the time of vaccination (B-cell depletion therapy, BCDT)
- On no immunomodulatory therapy for their autoimmune condition for \>6 months at the time of vaccination
- Treated with a non-BCDT immunotherapy
- No relapse of neurologic/immunologic disease for \>6 months prior to the time of enrollment
- Subject is eligible and willing to receive COVID-19 vaccination in accordance with local and national guidelines, or subject intends to receive booster COVID-19 vaccination in accordance with recommendations from their primary medical team.
- No active skin condition (e.g. open sores) preventing blood draw
- Healthy Controls:
- at least 18 years of age
- No evidence of neurological/immunologic disease/illness/condition
- Subject is eligible and willing to receive COVID-19 vaccination in accordance with local and national guidelines, or subject intends to receive booster COVID-19 vaccination in accordance with recommendations from their primary medical team.
- No active skin condition (e.g. open sores) preventing blood draw/skin biopsy
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.