Back to resultsHumoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions (COGEVAX-BIO)
Primary Purpose
Elderly People Institutionalized in Long-term Care Services
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly
Sponsored by
About this trial
This is an interventional screening trial for Elderly People Institutionalized in Long-term Care Services focused on measuring mRNA BNT162b2 vaccine, Coronavirus desease 2019 (Covid-19), anti-RBD IgG, vaccine antibodies, blood sample
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.
Sites / Locations
- Geriatric Department, Charles Foix hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Elderly person
Younger adults (priority caregivers)
Arm Description
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
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
Outcomes
Primary Outcome Measures
Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)
Secondary Outcome Measures
Measure plasma concentration of anti-RBD IgG antibodies in younger adults using SARS-CoV-2 IgG II Quant assay technique (Abbott)
Assess the percentage of patients with previous COVID-19 infection prior to vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961502
Brief Title
Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
Acronym
COGEVAX-BIO
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gérond'if
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly People Institutionalized in Long-term Care Services
Keywords
mRNA BNT162b2 vaccine, Coronavirus desease 2019 (Covid-19), anti-RBD IgG, vaccine antibodies, blood sample
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elderly person
Arm Type
Experimental
Arm Description
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
Arm Title
Younger adults (priority caregivers)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Assess the percentage of patients with previous COVID-19 infection prior to vaccination
Time Frame
At inclusion
Other Pre-specified Outcome Measures:
Title
Assessment the percentage of patients who developed anti-RBD antibodies after vaccination by blood sample
Time Frame
50 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Dufour
Phone
+33 (0)185781010
Email
isabelle.dufour@gerondif.org
First Name & Middle Initial & Last Name or Official Title & Degree
Adrien Besseivhe
Phone
+33 (0)185781010
Email
adrien.besseiche@gerondif.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joël Belmin, MD PhD
Organizational Affiliation
Geriatric Department, Charles Foix hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Geriatric Department, Charles Foix hospital
City
Ivry-sur-Seine
State/Province
IIe-de-France
ZIP/Postal Code
94200
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
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