Allergy and COVID-19 Vaccines

NCT05028257 | Completed Phase 3

• 2 other identifiers: P 2106412021-003155-42
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaphylactic Reaction; Vaccine Reaction

Keywords

Anaphylactic reactions; COVID-19 vaccines; PEG2000; tromethamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine the involvement of excipients in anaphylactic reactions

  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.

  from Week 9 to Month 9

Study Arms (1)

COVID-19 Vaccinated Patients

EXPERIMENTAL

Biological: COVID-19 Vaccines

Interventions

COVID-19 Vaccines BIOLOGICAL

Pursuit of vaccination in case of anaphylactic reaction

Also known as: Janssen COVID19 vaccine, Astra Zeneca COVID19 vaccine, Comirnaty Pfizer COVID19 vaccine, Moderna COVID19 vaccine

COVID-19 Vaccinated Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Tenon Hospital APHP dermatology and allergology department

Paris, 75020, France

Location

MeSH Terms

Conditions

Anaphylaxis

Interventions

COVID-19 Vaccines; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• Angèle SORIA, PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 31, 2021
• Study Start: September 15, 2021
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)