Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
NCT ID: NCT04961502
Last Updated: 2021-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2021-03-11
2021-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Elderly person
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
Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly
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
Younger adults (priority caregivers)
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
Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly
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
Interventions
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Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly
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
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
18 Years
ALL
Yes
Sponsors
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Gérond'if
OTHER
Responsible Party
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Principal Investigators
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Joël Belmin, MD PhD
Role: STUDY_CHAIR
Geriatric Department, Charles Foix hospital
Locations
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Geriatric Department, Charles Foix hospital
Ivry-sur-Seine, IIe-de-France, France
Countries
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Central Contacts
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Other Identifiers
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2021-A00051-40
Identifier Type: -
Identifier Source: org_study_id
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