Clinical trial NCT04760704: Covid-19 Vaccine Response in Elderly Subjects
Official title: Evaluation of the Immunogenicity of mRNA BNT162b2 (COMIRNATY®) Vaccine in Elderly Subjects by Monitoring the Specific Cellular and Humoral Response.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19 Vaccine
Keywords: SARS-CoV-2
vaccination
immunosenescence
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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)

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine
timeFrame: At 3 months after the first vaccine administration
Secondary outcomes:
measure: Specific CD4+ and CD8+ T cell response
timeFrame: At 3 months and at 9 months after vaccine administration
measure: Total anti-S and neutralizing antibody levels
timeFrame: At 3 months and at 9 months after vaccine administration
measure: Specific immune response according to presence/absence of pre-vaccine antibodies
timeFrame: At 3 months and at 9 months after vaccine administration
measure: Specific immune response after COVID-19 vs after BNT162b2 mRNA vaccine
timeFrame: At 3 months after vaccine administration
measure: Specific immune response according to nutritional status
timeFrame: At 3 months and at 9 months after vaccine administration
measure: 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
timeFrame: At 3 months and at 9 months after vaccine administration
measure: Peripheral blood mononuclear cells and serum collection
timeFrame: 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.
measure: 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)
timeFrame: at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)
measure: 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).
timeFrame: Before the booster and 3, 6 and 12 months after the booster
measure: 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).
timeFrame: within 24-48 hours of a positive PCR
measure: Saliva samples
timeFrame: at the time of a COVID-19 diagnosis and 3 months after diagnosis, before vaccination or 3, 6 and 12 months after booster.
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU lille
Study officials:
affiliation: University Hospital, Lille
name: Guillaume LEFEVRE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: