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Twelve months after the first SARS-CoV-2 cases in Wuhan, the FDA approved the first COVID-19 vaccine (Pfizer-BioNTech). Early studies on healthcare workers showed that antibody levels, especially against the Spike protein, declined within six months, particularly in those without prior infection. However, previously infected individuals had stronger and longer-lasting responses. The vaccine induces a Th1-type T cell response, linked to milder disease, and activates follicular helper T cells and B cell responses, although antibody levels drop over time. Immune responses also differ by sex, with females showing stronger humoral responses. Key priorities include understanding humoral fluctuations, characterizing cellular immunity, and correlating both responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 107 healthcare workers who completed the vaccination cycle for SARS-CoV-2 | T cell response in terms of IFN-γ measured by ELISpot |
| |
| 20 healthy donors who didn't receive SARS-CoV-2 vaccination | T cell response in terms of IFN-γ measured by ELISpot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of the T cell response in terms of IFN-γ measured by ELISpot | Other | The evaluation of the T cell response will be performed by quantifying the frequencies of SARS-CoV-2-specific T cells producing IFN-γ using an enzyme-linked immunospot assay (ELISpot), with cryopreserved PBMC collected at the designated timepoints (T0, T1, T2, T3, and T4) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the existence of a correlation between the antibody titer six months after the second dose and the T and B cell responses | Correlation between antibody titer, in terms of antibodies directed against the Spike protein, and T cell response, in terms of IFN-γ measured by ELISpot, as well as B cell response, in terms of frequency and phenotype, assessed six months after the second dose (T3) | Six months after the second vaccine dose, which coincides with the time of enrollment |
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healthcare workers group
Inclusion Criteria:
Age ≥18 years
Completion of the SARS-CoV-2 vaccination cycle with the Pfizer-BioNTech vaccine
Informed consent for the storage of biological material at the San Raffaele Hospital Biological Resource Center (with protocol related to the BioVAC study approved by the Ethics Committee: 17/INT/2022)
Availability of at least two aliquots of PBMC collected at the completion of the vaccination cycle and frozen at the CRB
Exclusion Criteria:
Inclusion Criteria:
- consent for sample collection and storage in the Biobank between 2016 and 2018
Exclusion Criteria:
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Approximately 405 biological samples will be analyzed in the study, collected from the OSR Biobank (with protocol related to the BioVAC study approved by the Ethics Committee: 17/INT/2022). These samples were obtained from healthcare workers who completed the SARS-CoV-2 vaccination cycle between January 2020 and November 2021.
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| Name | Affiliation | Role |
|---|---|---|
| Patrizia Rovere Querini, PhD, MD | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | Italy | 20132 | Italy |
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Aliquots of PBMC collected at the completion of the vaccination cycle and frozen at the CRB
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