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Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients

CompletedN/A

Sponsor: Yale University

Conditions: Multiple Sclerosis, Autoimmune Blistering Disease, B-Cell Deficiency

Interventions: COVID19 vaccine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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

Locations (1)

New Haven, Connecticut, United States