NCT04760704CompletedNot Applicable
Evaluation of the Immunogenicity of mRNA BNT162b2 (COMIRNATY®) Vaccine in Elderly Subjects by Monitoring the Specific Cellular and Humoral Response.
University Hospital, Lille1 site in 1 country264 target enrollmentStarted: February 18, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 264
- Locations
- 1
- Primary Endpoint
- Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental group
Persons aged 65 and over, residing in an institution for dependant elderly or in a long-term care unit
Intervention: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration (Biological)
control group
Health and medico-social professionals between 40 and 65 years of age
Intervention: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration (Biological)
Outcomes
Primary Outcomes
Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine
Time Frame: At 3 months after the first vaccine administration
Number of gamma interferon-producing anti-S specific T cells detected 3 months after the first vaccine administration between elderly and control subjects
Secondary Outcomes
- Specific immune response according to presence/absence of pre-vaccine antibodies(At 3 months and at 9 months after vaccine administration)
- Specific CD4+ and CD8+ T cell response(At 3 months and at 9 months after vaccine administration)
- 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)(at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis))
- 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.)
- 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)
- Total anti-S and neutralizing antibody levels(At 3 months and at 9 months after vaccine administration)
- 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)
- Specific immune response after COVID-19 vs after BNT162b2 mRNA vaccine(At 3 months after vaccine administration)
- Peripheral blood mononuclear cells and serum collection(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.)
- Specific immune response according to nutritional status(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)
Investigators
Study Sites (1)
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