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COVID-19 vaccine response under scrutiny in autoimmune patients

NCT ID NCT04870411

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at how well the COVID-19 vaccine triggers an immune response in people with autoimmune or inflammatory diseases who take immunosuppressants or biologics. Researchers took blood samples before vaccination and at several points after to measure antibodies and T-cells. The study was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
COVID-19 vaccine (immune response measured via blood samples)
What this could lead to
If successful, this could help doctors understand how well COVID-19 vaccines work in people with autoimmune diseases taking immune-suppressing drugs.
What could go wrong
The study was terminated early with only 78 participants, so results may be limited and not apply to all patients. Immune response may still be weak in some groups.

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

78 people

The number who actually took part.

Started

May 2021

Finished

Mar 2022

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

Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics = 170 patients Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics = 30 patients

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: * Group 1 : * Patient over 18 years old, * Patient informed and not opposed to participate * Patient followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis) * Treatment with immunosuppressant and / or immunomodulator * Group 2 : * Patient over 18 years old, * Patient informed and not opposed to participate * Patient not followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis) * Absence of treatment with immunosuppressant and / or immunomodulator Exclusion Criteria: * Contraindication to vaccination * Progressive cancer * Pregnant or breastfeeding woman * Current infection less than 3 weeks old * Weight less than 40 kg * Patient under tutor- or curator-ship * Patient without health insurance

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Conditions

The condition(s) this trial relates to.

autoimmune disease COVID-19 inflammatory disease systemic lupus erythematosus systemic sclerosis uveitis vasculitis

As listed by the trial registrant

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

Autoimmune diseases Inflammatory disorder

Contacts and locations

Locations

  • Internal medicine Service - Cochin Hospital

    Paris, 75014, France

More trials for these conditions

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