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Spike-specific Cellular Immune Response After COVID-19 Vaccination

Spike-specific Cellular Immune Response After COVID-19 Vaccination

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05102669
Acronym
RIS-COV
Enrollment
53
Registered
2021-11-01
Start date
2021-03-12
Completion date
2021-10-11
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID19, Immune Response, Vaccination

Brief summary

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.

Detailed description

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.

Interventions

OTHERanalysis of immunological response

collection and analysis of SARS-CoV2 Spike specific blood cells

DIAGNOSTIC_TESTanalysis of serum antibodies

analysis of anti-SARS-CoV2 Spike specific antibodies

Sponsors

IRCCS San Raffaele Roma
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* vaccinated and non vaccinated subjects * subjects that never tested positive for COVID19

Exclusion criteria

* subjects that tested positive for COVID-19

Design outcomes

Primary

MeasureTime frameDescription
measurement of cellular response7 monthsevaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026