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Study reveals vaccine response in Immune-Compromised patients

NCT ID NCT05286242

Knowledge-focused Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how people with autoimmune diseases like multiple sclerosis or blistering skin conditions respond to COVID-19 vaccines while on B-cell depleting therapies. Researchers measured antibody levels and T-cell activity over time to understand vaccine effectiveness in this group. The goal is to help doctors make better vaccination decisions for immunodeficient patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

196 people

The number who actually took part.

Started

Feb 2021

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

There will be four groups of participants overall: * Patients with autoimmune neurologic/autoimmune blistering disease (AIBD) who are on B-cell depleting therapy (anti-CD20 monoclonal antibodies) * Patients with autoimmune neurologic/AIBD who are on other types of immunomodulators * Patients with autoimmune neurologic/AIBD who are untreated * Healthy controls

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

autoimmune bullous skin disease B cell deficiency multiple sclerosis myelin oligodendrocyte glycoprotein antibody-associated disease neuromyelitis optica

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune blistering disease B-cell deficiency Multiple sclerosis

Contacts and locations

Locations

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.