NCT04760704

Brief Summary

The objective of this research is to assess the amplitude and quality of the vaccine response against SARS-CoV-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared to immunocompetent subjects aged 40 to 65 years (control subjects for vaccination over the same period).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

December 26, 2025

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

February 17, 2021

Last Update Submit

December 18, 2025

Conditions

Covid19 Vaccine

Keywords

SARS-CoV-2vaccinationimmunosenescence

Outcome Measures

Primary Outcomes (1)

  • Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine

    Number of gamma interferon-producing anti-S specific T cells detected 3 months after the first vaccine administration between elderly and control subjects

    At 3 months after the first vaccine administration

Secondary Outcomes (11)

  • Specific CD4+ and CD8+ T cell response

    At 3 months and at 9 months after vaccine administration

  • Total anti-S and neutralizing antibody levels

    At 3 months and at 9 months after vaccine administration

  • Specific immune response according to presence/absence of pre-vaccine antibodies

    At 3 months and at 9 months after vaccine administration

  • Specific immune response after COVID-19 vs after BNT162b2 mRNA vaccine

    At 3 months after vaccine administration

  • Specific immune response according to nutritional status

    At 3 months and at 9 months after vaccine administration

  • +6 more secondary outcomes

Study Arms (2)

Experimental group

Persons aged 65 and over, residing in an institution for dependant elderly or in a long-term care unit

Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration

control group

Health and medico-social professionals between 40 and 65 years of age

Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration

Interventions

Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administrationBIOLOGICAL

Specific T cells and specific antibodies assessment

Experimental groupcontrol group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly persons \> 65 years of age residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)

You may qualify if:

  • Target population.
  • Elderly persons \> 65 years old residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)
  • Male or female resident in an institution for the elderly or in a long-term care unit
  • For whom consent has been obtained prior to any SARS-CoV-2 vaccination (or from the legal guardian/curator) by COMIRNATY®.
  • Having consented to participate in the study, and willing to comply with all study procedures and its duration
  • Socially insured patient
  • Control population
  • Health and medico-social sector professionals aged between 40 and 65 years old for whom a COMIRNATY® anti-SARS-CoV-2 vaccination is indicated as recommended by the HAS.
  • Male or female between 40 and 65 years of age included
  • For whom consent has been obtained prior to any COMIRNATY® SARS-CoV-2 vaccination.
  • Having consented to participate in the study, and willing to comply with all study procedures and its duration
  • Socially insured subject

You may not qualify if:

  • Progressive infectious pathology
  • Progressive neoplastic pathology (or remission of \< 5 years)
  • Treatment with long-term corticosteroids or immunosuppressants
  • Refuse of consent to vaccination or study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum blood collection

Study Officials

  • Guillaume LEFEVRE, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 18, 2021

Study Start

February 18, 2021

Primary Completion

March 28, 2023

Study Completion

March 28, 2023

Last Updated

December 26, 2025

Record last verified: 2022-04

Locations

FR(1)