Clinical trial NCT04961502: Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
Official title: Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly People Institutionalized in Long-term Care Services
Keywords: mRNA BNT162b2 vaccine
Coronavirus desease 2019 (Covid-19)
anti-RBD IgG
vaccine antibodies
blood sample
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers)
Primary purpose: SCREENING

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)
timeFrame: 50 days
Secondary outcomes:
measure: Measure plasma concentration of anti-RBD IgG antibodies in younger adults using SARS-CoV-2 IgG II Quant assay technique (Abbott)
timeFrame: 50 days
measure: Assess the percentage of patients with previous COVID-19 infection prior to vaccination
timeFrame: At inclusion
Other outcomes:
measure: Assessment the percentage of patients who developed anti-RBD antibodies after vaccination by blood sample
timeFrame: 50 days
Locations:
city: Ivry-sur-Seine
country: France
facility: Geriatric Department, Charles Foix hospital
state: IIe-de-France
Study officials:
affiliation: Geriatric Department, Charles Foix hospital
name: Joël Belmin, MD PhD
role: STUDY_CHAIR
References: