An observational study in Covid19 Vaccine, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by University Hospital, Lille · Observational
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).
University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Target population.
Control population
Exclusion Criteria, for both groups :
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
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
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
Time frame: At 3 months after the first vaccine administration
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
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.
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.
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)
Time frame: 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
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
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.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille