Clinical Trials

Allergy and COVID-19 Vaccines

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05028257
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique - Hôpitaux de Paris
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Angèle SORIA, PUPH
Principal Investigator Affiliation	Assistance Publique - Hôpitaux de Paris
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anaphylactic Reaction, Vaccine Reaction

Additional Details

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.

Arms & Interventions

Arms

Experimental: COVID-19 Vaccinated Patients

Interventions

Biological: - COVID-19 Vaccines

Pursuit of vaccination in case of anaphylactic reaction

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Paris, France

Status

Recruiting

Address

Tenon Hospital APHP dermatology and allergology department

Paris, , 75020

Site Contact

Angèle SORIA, PU-PH

angele.soria@aphp.fr

0156017220

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