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

Not Applicable

• Conditions: Elderly People Institutionalized in Long-term Care Services

• Registration Number: NCT04961502
• Lead Sponsor: Gérond'if

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.

Study Timeline

• Study Start: 2021-03-11
• Status Verified: 2021-06
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-12
• Study First Posted: 2021-07-14
• Last Update Posted: 2021-07-14
• Primary Completion: 2021-08
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)	50 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Geriatric Department, Charles Foix hospital; 🇫🇷 Ivry-sur-Seine, IIe-de-France, France