Multicentre national cohort study with prospective data collection and biological specimen collection. Ancillary study in this cohort : pediatric cohort with participants from 5 to 17 years old. Enrollment complete for adult cohort. Active recruting for ancillary pediatric cohort.
Primary Objective 1.Evaluate in a standardized manner in each subpopulation the humoral immune response to Covid-19 vaccination at 1, 6, 12, 24 months (M) after the last dose of vaccine (1 or 2 dose schedule depending on the vaccines) and standardized assessment of the humoral response 1 month after receipt of the third injection in participants receiving a third injection as recommended Secondary objectives 1. Evaluate the cellular immune response to Covid-19 vaccination at Inclusion, 6 and 24 months after the first injection (single-injection scheme) or after the second injection of the vaccine (two or three-injections regimens) in each subpopulation 2. Compare the humoral immune response at 1, 6, 12, 24 months after the first injection (one-injection scheme) or after the second injection of vaccine (two- or three-injections regimens) of each subpopulation with a control group of subjects without the chronic diseases of interest and from any other diseases or treatment taht may have an influence on the immune response. 3. Compare the humoral immune response after 3 injections (1 month after the third dose) to that after 2 injections (1 month after the second dose) in participants with received a third injection as current recommendations 4. In each subpopulation, study the factors associated with the humoral immune response at 1 month and the persistence of the humoral immune response at 6, 12, 24 months as a function of age, stage of disease, treatments, type of vaccine (as well as characteristics specific to the subpopulations studied) 5. Evaluate and characterize the humoral immune response for participants who received a booster dose with mRNA vaccine acording to recommendations in force 6. Compare the humoral immune response between different specific subpopulations 7. Describe the seroconversion for anti-nucleoprotein antibodies 8. Immuno-virologically characterize vaccine failures (SARS-CoV2 infection) during follow-up 9. Identify genetic determinants of the immune response based on the underlying pathology and ongoing treatments if applicable (response and resistance to vaccination) Specifics secondary objectives for participants with the first dose of Astra-Zeneca vaccine and the second dose of Pfizer vaccine 1. Evaluate the humoral and the cellular immune response to Covid-19 vaccination with this vaccination schedule 2. Evaluate the clinical reaction (local and generale) after this vaccination schedule
Study Type
OBSERVATIONAL
Enrollment
6,920
Vaccination done as part of France's COVID-19 Vaccination Campaign
Cmg-Ec U1219
Bordeaux, France
Nîmes CHU
Nîmes, France
Paris Cochin APHP
Paris, France
These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 2 serological criteria:
* Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Time frame: before the second injection (if applicable)
Humoral immunity to Covid-19 vaccination using 2 serological criteria:
* Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Time frame: Month 1
Humoral immunity to Covid-19 vaccination using 2 serological criteria:
* Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) * Seroneutralization for participants having test 1 and / or test 2 positive: percentage of patients with a titre ≥40 * Titre of neutralizing antibodies for participants having test 1 positive (with conventionnal in vitro neutralization test and neutralization test on variants of SARS-CoV-2)
Time frame: Month 1 after the third dose (if applicable)
Humoral immunity to Covid-19 vaccination using 2 serological criteria:
* Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
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Time frame: Month 6
Humoral immunity to Covid-19 vaccination using 2 serological criteria:
* Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Time frame: Month 12
Humoral immunity to Covid-19 vaccination using 2 serological criteria:
* Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Time frame: Month 24
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Time frame: Inclusion
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Time frame: before the second injection (if applicable)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Time frame: Month 1
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Time frame: Month 6
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Time frame: Month 12
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Time frame: Month 24
Seroconversion or increase of factor 2 titer of antibodies anti-Spike/anti-RBD between the second and the third dose for the participants with 3 injections
(qualitative Elisa)
Time frame: Month 1 after the third dose
Seroconversion or increased levels of anti-Spike/anti-RBD antibodies between the last injection of the initial vaccine regimen and the booster dose
(qualitative Elisa)
Time frame: Month 1 after the booster dose
These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination
ELISpot Test
Time frame: Inclusion
Cellular immunity to Covid-19 vaccination
ELISpot Test
Time frame: Month 6
Cellular immunity to Covid-19 vaccination
ELISpot Test
Time frame: Month 24
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : humoral and cellular immunity to Covid-19 vaccination
qualitative Elisa and ELISpot Test
Time frame: Inclusion
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : humoral and cellular immunity to Covid-19 vaccination
qualitative Elisa and ELISpot Test
Time frame: Month 1
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of immediate adverse effects
collection by a self-monitoring log
Time frame: within 15 minutes after injection of Pfizer ARNm vaccine
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of adverse effects expected from the database
collection by a self-monitoring log
Time frame: within 7 days after injection of Pfizer ARNm vaccine
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of adverse effects
collection by a self-monitoring log
Time frame: within 28 days after injection of Pfizer ARNm vaccine