Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT04961502
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2021-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
Sponsor:
Gérond'if
Organization:
Study Overview
Official Title:
Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGEVAX-BIO
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: