COVALL: Allergy and COVID-19 Vaccines

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT05028257

Collaborator

(none)

120

Enrollment

Location

Arm

7.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anaphylactic Reaction Vaccine Reaction	Biological: COVID-19 Vaccines	Phase 3

Detailed 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

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pursuit of Vaccination in Anaphylactic Reaction to COVID19 Vaccines

Actual Study Start Date :

Sep 15, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Describe the continuation of vaccination and its tolerance in case of negative allergological investigation. [from Week 9 to Month 9]
Proportion of patient without anaphylactic reaction during second vaccination

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Anaphylactic reaction at least 3 weeks old prior to allergology consultation, when administered a COVID-19 vaccine.

Anaphylactic reaction is defined as the occurrence within hours of administration of a COVID-19 vaccine of any of the following systemic manifestations; skin rash such as urticaria and/or angiodema, associated with respiratory signs (dyspnea, bronchospasm, desaturation), and/or digestive disorders (severe abdominal pain, diarrhea, vomiting, nausea), and/or neurological disorders (loss of consciousness, feeling of faintness), 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