Status:
ACTIVE_NOT_RECRUITING
Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Robert Leet and Clara Guthrie Patterson Trust
Conditions:
Multiple Sclerosis
Autoimmune Blistering Disease
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
This will be a prospective, observational cohort study consisting of individuals with autoimmune diseases who are undergoing treatment with anti-CD20 medications at the time they receive a vaccine aga...
Eligibility Criteria
Inclusion
- 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
- Exclusion Criteria:
- Use of high dose steroids for treatment of neurologic/immunologic disease within 1 month of COVID-19 vaccination
- Anti-CD20 B-cell depleting therapy infused within 2 weeks of first study visit
- Inability to comply with the requirements of the protocol, in the opinion of the primary investigator
Exclusion
Key Trial Info
Start Date :
February 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05286242
Start Date
February 10 2021
End Date
June 30 2026
Last Update
April 25 2025
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06520