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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00119-32 | Other Identifier | ID-RCB number, ANSM |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Persons aged 65 and over, residing in an institution for dependant elderly or in a long-term care unit |
| |
| control group | Health and medico-social professionals between 40 and 65 years of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration | Biological | Specific T cells and specific antibodies assessment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Target population.
Control population
Exclusion Criteria, for both groups :
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume LEFEVRE, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU lille | Lille | 59037 | France |
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serum blood collection
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. |