Covid-19 Vaccine Response in Elderly Subjects

Study Overview
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Brief Summary
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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).

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

Conditions
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Covid19 Vaccine

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group<br>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<br>* Specific T cells and specific antibodies assessment<br>|
| control group<br>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<br>* Specific T cells and specific antibodies assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific CD4+ and CD8+ T cell response | 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 | 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 | 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 | 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 | 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 |  | At 3 months and at 9 months after vaccine administration | 
| Peripheral blood mononuclear cells and serum collection | 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) | 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). |  | 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). |  | within 24-48 hours of a positive PCR | 
| Saliva samples |  | at the time of a COVID-19 diagnosis and 3 months after diagnosis, before vaccination or 3, 6 and 12 months after booster. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, vaccination, immunosenescence