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

April 9, 2024 updated by: IRCCS San Raffaele Roma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00163
        • IRCCS San Raffaele Roma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

IRCCS San Raffaele Roma health care workers

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • subjects that tested positive for COVID-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
vaccinated
COVID19 vaccinated subjects
Other: analysis of immunological response
collection and analysis of SARS-CoV2 Spike specific blood cells
Diagnostic test: analysis of serum antibodies
analysis of anti-SARS-CoV2 Spike specific antibodies
non vaccinated
COVID19 non vaccinated subjects
Other: analysis of immunological response
collection and analysis of SARS-CoV2 Spike specific blood cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of cellular response
Time Frame: 7 months
evaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Investigators

  • Principal Investigator: Laura Vitiello, PhD, IRCCS San Raffaele Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2021

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 11, 2021

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 20/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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