Allergy and COVID-19 Vaccines

Vaccine Reaction Clinical Trial

— COVALL  

Official title:

Pursuit of Vaccination in Anaphylactic Reaction to COVID19 Vaccines

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05028257
• Other study ID #: P 210641
• Secondary ID: 2021-003155-42
• Status: Recruiting
• Phase: Phase 3
• Start date: September 15, 2021
• Est. completion date: May 2022

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Angèle SORIA, PUPH
• Phone: 0156017220
• Email: angele.soria[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaphylactic Reaction
• Anaphylaxis
• COVID-19
• Shock
• Vaccine Reaction

Intervention

Biological:
• COVID-19 Vaccines
Pursuit of vaccination in case of anaphylactic reaction

Locations

Country	Name	City	State
France	Tenon Hospital APHP dermatology and allergology department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine the involvement of excipients in anaphylactic reactions	Proportion of patient with positive skin tests for excipients (PEG2000, PS80) or COVID-19 vaccines	from Week 9 to Month 9
Secondary	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.	Proportion of patient with positive allergological explorations (anamnesis, skin tests or biological test for excipients or vaccines)	from Week 9 to Month 9