Multiple Sclerosis Clinical Trial
Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients
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 to inform clinical decision making in this patient population.
Full 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 against COVID-19. Control groups will include healthy individuals, individuals with autoimmune diseases on other immunomodulators, and individuals with autoimmune diseases not on immunotherapy.
Participants will undergo serial blood draws and saliva collections at prespecified time points surrounding vaccination. A subset of agreeable participants will undergo skin biopsy within days of the first vaccination, with the option to repeat skin biopsy after the second vaccination. Additional blood, saliva and skin biopsy specimens may be obtained after booster vaccinations or after known COVID19 infections .
Specimens collected will be used for studies aimed at (1) understanding the pathobiology of neurologic/inflammatory/immune diseases and the immunologic response to COVID-19 vaccination, (2) identifying how and why treatments used for neurologic/immune diseases may impact the effectiveness of vaccination, and (3) identifying dermatologic manifestations of the immunologic response to the COVID-19 mRNA vaccine.
The investigators are investigating both the production of antibodies against the virus over time and deeply interrogating the T-cell response to vaccination using methods that measure T-cell reactivity to the COVID-19 virus, including single cell RNA sequencing.
Eligibility Criteria
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
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There is 1 Location for this study
New Haven Connecticut, 06520, United States
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