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Can people who reacted badly to a COVID shot still get vaccinated?

NCT ID NCT05028257

Diagnosis 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Some people have a severe allergic reaction, called anaphylaxis, after a COVID-19 vaccine. This study checks whether those people can safely receive another dose. Researchers also run allergy tests to find out which vaccine ingredients, such as PEG2000 or PS80, might cause the reactions. The goal is to help doctors decide who can continue vaccination and who should not.

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 vaccines from Pfizer-BioNTech, Moderna, AstraZeneca, or Janssen
What this could lead to
If the approach works, doctors could offer a clear path for people with a history of severe vaccine reactions to complete COVID-19 vaccination safely.
What could go wrong
This is a small study of 117 people, and results may not apply to everyone. Some participants could have another allergic reaction during testing or revaccination.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

117 people

The number who actually took part.

Started

Sep 2021

Finished

May 2023

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.

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: * Age ≥ 18 years * Anaphylactic reaction to a COVID-19 vaccine administered by Pfizer-BioNtech or Janssen or Vaxzevria or Moderna, at least 3 weeks old at the time of the allergology consultation. An anaphylactic reaction is defined as the occurrence of any of the following systemic manifestations within a few hours of administration of a COVID-19 vaccine: * skin rash with urticaria and/or angiodema, * and/or associated with respiratory signs (dyspnea, bronchospasm, desaturation), and/or digestive disorders (intense abdominal pain, diarrhea, vomiting, nausea), and/or neurological disorders (loss of consciousness, feeling of malaise), and/or hypotension, tachycardia. * Affiliation to a Social Security system * Signature of the informed consent * Stop taking antihistamines at least 3 days before skin allergy tests are performed Exclusion Criteria: * Other non-anaphylactic systemic reactions after administration of COVID-19 mRNA vaccine (serum sickness, vasculitis, Guillain-Barré syndrome) * Pregnancy and lactation * Disorders of hemostasis or severe bleeding considered a contraindication to intramuscular injection

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Conditions

The condition(s) this trial relates to.

anaphylaxis

As listed by the trial registrant

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

Anaphylactic reaction Vaccine reaction

Contacts and locations

Locations

  • Tenon Hospital APHP dermatology and allergology department

    Paris, 75020, France

More trials for these conditions

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