Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients
NCT ID: NCT05286242
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
400 participants
OBSERVATIONAL
2021-02-10
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy control
Healthy controls Participants will receive COVID19 vaccination according to standard of care (any FDA approved vaccine). They will donate serial biospecimens before and after vaccination according to the study design.
COVID19 vaccine
All participants receive one or more FDA-authorized COVID19 vaccinations according to standard of care and current medical recommendations. The intervention is not specifically administered as part of the study.
Disease control
Disease controls (individuals with a qualifying autoimmune condition, but not treated with any immunomodulator).
Participants will receive COVID19 vaccination according to standard of care (any FDA approved vaccine). They will donate serial biospecimens before and after vaccination according to the study design.
COVID19 vaccine
All participants receive one or more FDA-authorized COVID19 vaccinations according to standard of care and current medical recommendations. The intervention is not specifically administered as part of the study.
B-cell depleted
Individuals with autoimmune disease (multiple sclerosis or autoimmune blistering disease) who are treated with B-cell depleting anti-CD20 monoclonal antibodies.
Participants will receive COVID19 vaccination according to standard of care (any FDA approved vaccine). They will donate serial biospecimens before and after vaccination according to the study design.
COVID19 vaccine
All participants receive one or more FDA-authorized COVID19 vaccinations according to standard of care and current medical recommendations. The intervention is not specifically administered as part of the study.
Other immunomodulator
Individuals with autoimmune disease (multiple sclerosis or autoimmune blistering disease) who are treated with a non-CD20 monoclonal antibody immunomodulator to treat their disease.
Participants will receive COVID19 vaccination according to standard of care (any FDA approved vaccine). They will donate serial biospecimens before and after vaccination according to the study design.
COVID19 vaccine
All participants receive one or more FDA-authorized COVID19 vaccinations according to standard of care and current medical recommendations. The intervention is not specifically administered as part of the study.
Interventions
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COVID19 vaccine
All participants receive one or more FDA-authorized COVID19 vaccinations according to standard of care and current medical recommendations. The intervention is not specifically administered as part of the study.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Robert Leet and Clara Guthrie Patterson Trust
UNKNOWN
Yale University
OTHER
Responsible Party
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Principal Investigators
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Erin Longbrake
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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