drugset / Trial / NCT05028257

Allergy and COVID-19 Vaccines

NCT05028257

Phase 3 Completed 117 enrolled Assistance Publique - Hôpitaux de Paris
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-09-15
Primary completion
2023-05-22
Completion
2023-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD1222 Vaccine
Subject Ad26.COV2.S Vaccine
Subject Elasomeran Messenger RNA (mRNA)

Indications