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The main objective of this study is to describe the humoral and cellular response to BNT162b2 vaccination in people over age 75 institutionalized in the long-term care units of the Paris Public Hospitals (APHP)
This is an interventional study with minimal risk and constraints, multicenter with biological collection. Two populations are studied: patients and members of care staff.
The following data will be collected:
Vaccination antibodies are measured using 3 blood sample:
The first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second on D21 (shortly before the vaccination booster injection) and the third on D50-54.
In addition, during the first sample, assays will be carried out informing us of your nutritional and inflammatory status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly person | Experimental | Three blood sample: the first carried out before the anti-COVID-19 vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection |
|
| Younger adults (priority caregivers) | Active Comparator | Three blood sample: the first carried out before the anti-COVID-19 vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly | Biological | 3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers): the first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection |
| Measure | Description | Time Frame |
|---|---|---|
| Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott) | 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure plasma concentration of anti-RBD IgG antibodies in younger adults using SARS-CoV-2 IgG II Quant assay technique (Abbott) | 50 days | |
| Assess the percentage of patients with previous COVID-19 infection prior to vaccination | At inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment the percentage of patients who developed anti-RBD antibodies after vaccination by blood sample | 50 days |
Inclusion Criteria for patients:
Inclusion Criteria for younger adults (priority care staff):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Dufour | Contact | +33 (0)185781010 | isabelle.dufour@gerondif.org | |
| Adrien Besseivhe | Contact | +33 (0)185781010 | adrien.besseiche@gerondif.org |
| Name | Affiliation | Role |
|---|---|---|
| Joël Belmin, MD PhD | Geriatric Department, Charles Foix hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric Department, Charles Foix hospital | Recruiting | Ivry-sur-Seine | IIe-de-France | 94200 | France |
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3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers)
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|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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