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
• Interventions: Biological: Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly

• 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

Arm && Interventions

Group	Intervention	Description
Elderly person	Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly	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)	Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly	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

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