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Spike-specific Cellular Immune Response After COVID-19 Vaccination (RIS-COV)

I

IRCCS San Raffaele Roma

Status

Completed

Conditions

Immune Response
Vaccination
COVID19

Treatments

Diagnostic Test: analysis of serum antibodies
Other: analysis of immunological response

Study type

Observational

Funder types

Other

Identifiers

NCT05102669
RP 20/09

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • subjects that tested positive for COVID-19

Trial design

53 participants in 2 patient groups

vaccinated
Description:
COVID19 vaccinated subjects
Treatment:
Other: analysis of immunological response
Diagnostic Test: analysis of serum antibodies
non vaccinated
Description:
COVID19 non vaccinated subjects
Treatment:
Other: analysis of immunological response

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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