Clinical Trials Logo

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

See also
  Status Clinical Trial Phase
Recruiting NCT04798677 - Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine N/A
Completed NCT03600428 - Safety of LAIV4 in Children With Asthma Phase 4
Completed NCT03400878 - Comparing Morbidity and Mortality Effects of Two Different Strains of BCG Phase 4
Enrolling by invitation NCT04576910 - Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China Phase 4
Not yet recruiting NCT05028322 - Evaluation of Intradermal Hepatitis B Vaccine After IMIQUIMOD's Application, in Cirrhotics Who Did Not Respond to the Usual Vaccine Regimen Phase 2
Recruiting NCT04883177 - Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101)
Active, not recruiting NCT04922944 - Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients
Not yet recruiting NCT04674462 - Understanding Poor Vaccine Responses to Hepatitis B Vaccination Phase 4
Recruiting NCT04268420 - A Trial For The Study of Falciparum Malaria Protein 013 Administered Via Intramuscular Injection in Healthy Adults Phase 1
Recruiting NCT04296279 - A Trial For The Study of Falciparum Malaria Protein 014 Administered Via Intramuscular Injection in Healthy Adults Phase 1
Completed NCT04854408 - Evaluation of the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers' Menstrual Patterns
Enrolling by invitation NCT04817917 - Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province Phase 4
Active, not recruiting NCT03176719 - Non-specific Effects of Vaccination on Mortality and Morbidity
Recruiting NCT04954651 - Assessment of the Immunization Levels Against Sars-Cov2 Virus in Subjects Who Have Received EU-approved COVID-19 Vaccines
Active, not recruiting NCT04979871 - SARS-CoV-2 Antibodies and Virus Neutralisation in a Cohort Vaccinted Against COVID-19
Not yet recruiting NCT04439435 - Evaluation of Immunoprotection Provided by Hepatitis B Vaccine After Birth in Healthy Children
Recruiting NCT03581734 - Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine Phase 3
Completed NCT04495569 - A Bridging Study of the SYN023 on Healthy Adult Subjects Phase 1/Phase 2
Recruiting NCT04905862 - Assessment of Immune Response After Vaccination Against COVID-19 in Patients Treated With Renal Replacement Therapy
Completed NCT03743688 - Kinetics of the Immune Response to Inactivated Influenza Vaccine in Healthy Adults