Clinical trial NCT05028257: Allergy and COVID-19 Vaccines
Official title: Pursuit of Vaccination in Anaphylactic Reaction to COVID19 Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anaphylactic Reaction
Vaccine Reaction
Keywords: Anaphylactic reactions
COVID-19 vaccines
PEG2000
tromethamine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Describe the continuation of vaccination and its tolerance in case of negative allergological investigation.
timeFrame: from Week 9 to Month 9
Secondary outcomes:
measure: Determine the involvement of excipients in anaphylactic reactions
timeFrame: from Week 9 to Month 9
measure: To determine with certainty the diagnosis of anaphylaxis in the face of a suspected anaphylactic reaction during the administration of a COVID-19 vaccine.
timeFrame: from Week 9 to Month 9
Other outcomes:
Locations:
city: Paris
country: France
facility: Tenon Hospital APHP dermatology and allergology department
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Angèle SORIA, PUPH
role: PRINCIPAL_INVESTIGATOR
References: