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Clinical Trial Summary

Prospective monocentric study designed firstly to estimate the proportion of patients who tolerated the continuation of the COVID-19 2nd injection (absence of anaphylactic manifestations). secondly, to know the proportion of definite anaphylactic reactions in cases of suspected anaphylaxis after the first administration of a COVID-19 vaccine the very complete allergological explorations with both the clinical side, skin tests and biological tests will allow us to highlight the responsibility or not of the components of the vaccine,in particular of the excipients (PEG2000, PS80 and tromethamine) in anaphylactic reactions to COVID-19 vaccines A biological collection will be set up during this clinical study in order to study the immunological mechanisms; the effector cells and the signalling pathways involved in these reactions.


Clinical Trial Description

Eligible patients who experience an anaphylactic reaction after the first COVID-19 vaccine injection as part of their routine vaccination will be identified through the hotline set up by our expert center. Three to five weeks after the anaphylactic reaction, the patients will be called for a consultation in the dermatology and allergology department of Tenon hospital for a complete allergological check-up. 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 received the 2nd dose of vaccine to ensure thatthere are no significant adverse events related to the COVID-19 vaccine. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05028257
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Angèle SORIA, PUPH
Phone 0156017220
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date August 2021
Completion date April 2022

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