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

Gérond'if

Status: Unknown

Conditions: Elderly People Institutionalized in Long-term Care Services

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04961502

2021-A00051-40

Details and patient eligibility

About

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)

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Elderly person

Experimental group

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

Treatment:

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

Younger adults (priority caregivers)

Active Comparator group

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

Treatment:

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