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).
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine
Timeframe: At 3 months after the first vaccine administration