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OpenTrials
Completed

NCT Number: NCT05028257

Allergy and COVID-19 Vaccines

Prospective and retrospective multicenter study to estimate the proportion of patients who tolerated continuation of COVID-19 vaccination (absence of anaphylactic manifestations).

secondly, to determine the proportion of definite anaphylactic reactions in cases of suspected anaphylaxis following administration of a COVID-19 vaccine.

Comprehensive allergological investigations involving clinical, skin and biological tests will enable us to determine whether or not vaccine components, and in particular excipients (PEG2000, PS80 and tromethamine), are responsible for anaphylactic reactions to COVID-19 vaccines.

A biological collection will be set up during this clinical study to study the immunological mechanisms, effector cells and signalling pathways involved in these reactions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tenon Hospital APHP dermatology and allergology department

Paris, 75020, France

About this study

Eligible patients will be identified via the pharmacovigilance centers and allergology hotlines set up in each center, according to the organization specific to each hospital site. .

The patient identified in this way will be contacted by the secretariat of each allergology center to schedule an allergology consultation at least 3 to 5 weeks after the reaction (the usual delay before exploring an anaphylactic reaction to avoid the risk of false negatives). Then, in the framework of a collegial meeting ,the patient's file will be reviewed in order to specify the history of the allergic disease and the modalities of subsequent COVID-19 vaccination.

A follow-up telephonique call at 6months will be made systematically for patients who have continued vaccination to ensure that there are no significant adverse events related to the COVID-19 vaccine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 Vaccines

Biological

Pursuit of vaccination in case of anaphylactic reaction

Other names: Janssen COVID19 vaccine, Astra Zeneca COVID19 vaccine, Comirnaty Pfizer COVID19 vaccine, Moderna COVID19 vaccine

Primary outcomes

  1. Describe the continuation of vaccination and its tolerance in case of negative allergological investigation.

    Time frame: from Week 9 to Month 9

    Proportion of patient without anaphylactic reaction during second vaccination

Secondary outcomes

  1. Determine the involvement of excipients in anaphylactic reactions

    Time frame: from Week 9 to Month 9

    Proportion of patient with positive skin tests for excipients (PEG2000, PS80) or COVID-19 vaccines

  2. To determine with certainty the diagnosis of anaphylaxis in the face of a suspected anaphylactic reaction during the administration of a COVID-19 vaccine.

    Time frame: from Week 9 to Month 9

    Proportion of patient with positive allergological explorations (anamnesis, skin tests or biological test for excipients or vaccines)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Pursuit of Vaccination in Anaphylactic Reaction to COVID19 Vaccines

Acronym: COVALL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2021
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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