Covid-19 Vaccine Response in Elderly Subjects (MONITOCOVAGING)

December 18, 2025 updated by: University Hospital, Lille

Evaluation of the Immunogenicity of mRNA BNT162b2 (COMIRNATY®) Vaccine in Elderly Subjects by Monitoring the Specific Cellular and Humoral Response.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

264

Contacts and Locations

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

Study Locations

  • France
      • Lille, France, 59037
        • CHU Lille

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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)

Description

Inclusion Criteria:

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

Exclusion Criteria, for both groups :

  • 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

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Specific T cells and specific antibodies assessment
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
Specific T cells and specific antibodies assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine
Time Frame: At 3 months after the first vaccine administration
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific CD4+ and CD8+ T cell response
Time Frame: At 3 months and at 9 months after vaccine administration
Comparison of number of anti-S specific CD4+ and CD8+ T cells detected at 3 and 9 months, between elderly and control subjects
At 3 months and at 9 months after vaccine administration
Total anti-S and neutralizing antibody levels
Time Frame: At 3 months and at 9 months after vaccine administration
Comparison of total anti-S and neutralizing antibody levels (to pseudo-viral particles and to live virus) at 3 and 9 months after vaccine administration between elderly and control subjects.
At 3 months and at 9 months after vaccine administration
Specific immune response according to presence/absence of pre-vaccine antibodies
Time Frame: At 3 months and at 9 months after vaccine administration
Comparison of anti-S specific T cells, anti-S total antibody and neutralising antibody levels at 3 and 9 months depending on the presence or absence of pre-vaccine antibodies compatible with previous infection in elderly subjects
At 3 months and at 9 months after vaccine administration
Specific immune response after COVID-19 vs after BNT162b2 mRNA vaccine
Time Frame: At 3 months after vaccine administration
Comparison of anti-S-specific total T-cell count, anti-S total antibody levels and neutralising antibody levels 3 months after COVID-19 infection (before any vaccination) and 3 months after vaccination (in subjects who had no COVID-19 before) in elderly subjects
At 3 months after vaccine administration
Specific immune response according to nutritional status
Time Frame: At 3 months and at 9 months after vaccine administration
Correlation between number of anti-S specific T cells, total anti-S antibody and neutralising antibody levels at 3 and 9 months and nutritional status of elderly subjects evaluated according to the Geriatric Nutritional Risk Index (GNRI) in elderly subjects.
At 3 months and at 9 months after vaccine administration
Correlation between number of T cells, total anti-S antibody and neutralising antibody at 3 and 9 months, and basal levels of proinflammatory cytokines (interleukin-6, TNF-alpha) in elderly subjects
Time Frame: At 3 months and at 9 months after vaccine administration
At 3 months and at 9 months after vaccine administration
Peripheral blood mononuclear cells and serum collection
Time Frame: before the first vaccine injection, 21 days after the first vaccine administration (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months.
Sampling and conservation of mononuclear cells and serum before injection, at D21 (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months, in elderly and control subjects.
before the first vaccine injection, 21 days after the first vaccine administration (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months.
Correlation between number of T cell , total anti-S and neutralizing antibody levels at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)
Time Frame: at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)
The neutralizing antibody level at 3 and 6 months will be compared to the levels observed during the infection (serologies done systematically, serum available for retro analysis)
at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)
Correlation between number of T-cell , total anti-S and neutralizing antibody levels before the booster and 3, 6 and 12 months after the booster (neutralization tests will be done on BA.1 and any variant of interest at the time of testing).
Time Frame: Before the booster and 3, 6 and 12 months after the booster
Before the booster and 3, 6 and 12 months after the booster
Correlation between number of T-cell counts, total anti-S and neutralizing antibody levels within 24-48 hours of a positive PCR (neutralization tests will be done on the variant of interest at the time of testing).
Time Frame: within 24-48 hours of a positive PCR
within 24-48 hours of a positive PCR
Saliva samples
Time Frame: at the time of a COVID-19 diagnosis and 3 months after diagnosis, before vaccination or 3, 6 and 12 months after booster.
at the time of a COVID-19 diagnosis and 3 months after diagnosis, before vaccination or 3, 6 and 12 months after booster.

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Guillaume LEFEVRE, MD,PhD, University Hospital, Lille

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)

February 18, 2021

Primary Completion (Actual)

March 28, 2023

Study Completion (Actual)

March 28, 2023

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021_02
  • 2021-A00119-32 (Other Identifier: ID-RCB number, ANSM)

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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