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OpenTrials
Completed

NCT Number: NCT04760704

Covid-19 Vaccine Response in Elderly Subjects

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).

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Key information

Conditions

Covid19 Vaccine

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

Specific T cells and specific antibodies assessment

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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)

  9. 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

  10. 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

  11. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: MONITOCOVAGING

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2021
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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