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

July 12, 2021 updated by: Gérond'if
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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • IIe-de-France
      • Ivry-sur-Seine, IIe-de-France, France, 94200
        • Recruiting
        • Geriatric Department, Charles Foix hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: 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
Active Comparator: 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
Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)
Time Frame: 50 days
50 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
50 days
Assess the percentage of patients with previous COVID-19 infection prior to vaccination
Time Frame: At inclusion
At inclusion

Other Outcome Measures

Outcome Measure
Time Frame
Assessment the percentage of patients who developed anti-RBD antibodies after vaccination by blood sample
Time Frame: 50 days
50 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gérond'if

Investigators

  • Study Chair: Joël Belmin, MD PhD, Geriatric Department, Charles Foix hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2021

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A00051-40

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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