Volunteer MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865
Conditions
Interventions
Trade Name: COVID-19 mRNA Vaccine (nucleoside modified) - Pfizer BioNTech - Comirnaty
Product Name: Comirnaty
Pharmaceutical Form: Concentrate for dispersion for injection
Trade Name: COVID-19 Vaccin
Sponsors
CHU de Saint Etienne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Volunteer aged = 18 years-old - For the group WITH a past history of COVID-19 (convalescents) = subject within = 3 months after infection - For the NO past history of COVID-19 (naives), subject with no known history of COVID-19 - Patient affiliated or entitled to a social security plan - Patients who have received informed information about the study and who have co-signed a consent to participate in the study with the investigator Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: o Immunocompromised or under immunosuppressive treatment or with a pathology (chronic infections, autoimmune) that the investigator considers would impact on the immune response o Subject with a history of COVID hospitalized in intensive care o Subject allergic to one of the components of the vaccines used in the study o subject vaccinated for COVID-19 o Subject with persistent symptoms of COVID-19 (long COVID) o Subjects with unstable chronic pathology o Persons deprived of liberty, hospitalized without consent, hospitalized for purposes other than research o Under guardianship or curatorship o Having received a vaccine in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the temporal kinetics of the pre- and post-vaccine neutralizing systemic humoral immune response to SARS-CoV-2 in the convalescent and naïve groups and by type of vaccine used and according to age;Secondary Objective: 1-Evaluate the temporal kinetics of the total systemic humoral immune response pre and post SARS-CoV-2 vaccine according to factors that may influence these kinetics (COVID-19 history and vaccine type and age) 2-Evaluate the temporal kinetics of the mucosal humoral immune response before and after SARS-CoV-2 vaccine according to the factors that may influence these kinetics (history of COVID-19 and type of vaccine and age) 3-Evaluate the temporal kinetics of the cellular immune response before and after the SARS-CoV-2 vaccine according to factors that may influence these kinetics (history of COVID-19 and type of vaccine, age) 4-Evaluate the post-vaccine SARS-CoV-2 reactogenic inflammatory response according to the factors that may influence these kinetics (history of COVID-19 and type of vaccine, age );Primary end point(s): Anti-SARS-CoV-2 -specific neutralizing antibody;Timepoint(s) of evaluation of this end point: at inclusion, 15 days, 3, 6 and 12 months post last vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Anti-SARS-CoV-2 antibody - Spike and Nucleocapsid (ELISA test) 2- Anti-SARS-CoV-2 - IgA antibody in saliva 3- Cellular response evaluated by SARS-CoV-2 quantiferon value and TruCulture method (Myriad) 4- Expression kinetics in foldchange 5- Biophysical (glycosylation, avidity, isotopes) and functional characteristics of antibodies anti-S;Timepoint(s) of evaluation of this end point: at inclusion, 15 days, 3, 6 and 12 months post last vaccination | — |
Countries
France
Contacts
Public Contactproject manager
CHU Saint Etienne
Outcome results
None listed