Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients (NCT05286242) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients
United States196 participantsStarted 2021-02-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 neur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in coronavirus disease 19 (COVID19) antibody titers over time
Timeframe: Baseline, 2 weeks post vaccine 1, pre-vaccine 2, 1 week post vaccine 2, 6 months post vaccine 2; pre- and 2 week post any additional vaccines
2
Change in severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) specific T-cell activation over time
Timeframe: Baseline, 2 weeks post vaccine 1, pre-vaccine 2, 1 week post vaccine 2, 6 months post vaccine 2; pre- and 2 week post any additional vaccines