An observational study in COVID19, Vaccination and Immune Response, sponsored by IRCCS San Raffaele Roma. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by IRCCS San Raffaele Roma · Observational
Aim of this study is to evaluate whether COVID-19 vaccination induces a persistent cellular immune response.
To this aim, blood samples are taken from vaccinated individuals and not immunized subjects as a control group.
Cells isolated from blood samples are tested in vitro to assess the percentage of spike-specific T and B lymphocytes 1 and 7 months after a second dose of Comirnaty vaccine.
After providing written informed consent, 28 vaccinated and 25 non vaccinated subjects were included in the study. All subjects were enrolled among healthcare workers in the Research Centre of IRCCS San Raffaele Roma in Rome.
All the subjects declared that they never tested positive for COVID19. Blood and serum samples were drowned twice from vaccinated subjects: 1 and 7 months after a second dose of vaccine to evaluate T and B response to vaccine; blood was drowned once in not vaccinated subjects.
Cells were collected form peripheral blood samples, while anti-S1 IgG titre was assessed in serum.
Flow-cytometry was used to assess the percentage of circulating spike-specific T and B lymphocytes.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 53 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →IRCCS San Raffaele Roma is the lead sponsor of 63 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
IRCCS San Raffaele Roma health care workers
Exclusion Criteria:
COVID19 vaccinated subjects
Other: analysis of immunological response · Diagnostic Test: analysis of serum antibodies
COVID19 non vaccinated subjects
Other: analysis of immunological response
collection and analysis of SARS-CoV2 Spike specific blood cells
analysis of anti-SARS-CoV2 Spike specific antibodies
measurement of cellular response
evaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination
Time frame: 7 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele Roma