Allergy and COVID-19 Vaccines (COVALL)

Pursuit of Vaccination in Anaphylactic Reaction to COVID19 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.

Study Overview

• Status: Completed
• Conditions: Vaccine Reaction; Anaphylactic Reaction
• Intervention / Treatment: Biological: COVID-19 Vaccines

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Tenon Hospital APHP dermatology and allergology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVID-19 Vaccinated Patients	Biological: COVID-19 Vaccines; Pursuit of vaccination in case of anaphylactic reaction; Other Names: Janssen COVID19 vaccine; Astra Zeneca COVID19 vaccine; Comirnaty Pfizer COVID19 vaccine; Moderna COVID19 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the continuation of vaccination and its tolerance in case of negative allergological investigation.	Proportion of patient without anaphylactic reaction during second vaccination	from Week 9 to Month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the involvement of excipients in anaphylactic reactions	Proportion of patient with positive skin tests for excipients (PEG2000, PS80) or COVID-19 vaccines	from Week 9 to Month 9
To determine with certainty the diagnosis of anaphylaxis in the face of a suspected anaphylactic reaction during the administration of a COVID-19 vaccine.	Proportion of patient with positive allergological explorations (anamnesis, skin tests or biological test for excipients or vaccines)	from Week 9 to Month 9

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Angèle SORIA, PUPH, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19 vaccines; Anaphylactic reactions; PEG2000; tromethamine
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hypersensitivity, Immediate; Hypersensitivity; COVID-19; Shock; Anaphylaxis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: P 210641; 2021-003155-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No