Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions

Gérond'if80 enrolled

Overview

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: * For patients and staff: age, gender, existence of Coronavirus Disease 2019 (COVID-19) infection and whether or not it is symptomatic and date of first positive RT-PCR test, medical history * For patients: nutritional status (loss of appetite, weight loss, body mass index, albuminemia) 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Elderly People Institutionalized in Long-term Care Services

Interventions

Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderlyBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria for patients: * Person aged 75 and over, * Hospitalized in a long-term care unit participating in the study, * Having agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities, * Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study, * Having given their written consent to participate in the study, or having not expressed their opposition to participating and whose legal guardian has given their consent. Inclusion Criteria for younger adults (priority care staff): * Staff who have agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities, * Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study, * Having given their written consent to participate in the study.

Locations (1)

Geriatric Department, Charles Foix hospital

Ivry-sur-Seine, IIe-de-France, France

RECRUITING

Outcomes

Primary Outcomes

Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)

Time frame: 50 days

Secondary Outcomes

Measure plasma concentration of anti-RBD IgG antibodies in younger adults using SARS-CoV-2 IgG II Quant assay technique (Abbott)

Time frame: 50 days

Assess the percentage of patients with previous COVID-19 infection prior to vaccination

Time frame: At inclusion

Central Contacts

Isabelle Dufour

CONTACT

+33 (0)185781010 isabelle.dufour@gerondif.org

Adrien Besseivhe

CONTACT

+33 (0)185781010 adrien.besseiche@gerondif.org

Data from ClinicalTrials.gov

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