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NCT05102669 Clinical Trial

Spike-specific Cellular Immune Response After COVID-19 Vaccination

COVID19 Clinical Trial

— RIS-COV  

Official title:
Spike-specific Cellular Immune Response After COVID-19 Vaccination

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05102669
Other study ID # RP 20/09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 12, 2021
Est. completion date October 11, 2021

Study information
Verified date April 2024
Source IRCCS San Raffaele Roma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date October 11, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - vaccinated and non vaccinated subjects - subjects that never tested positive for COVID19 Exclusion Criteria: - subjects that tested positive for COVID-19

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy IRCCS San Raffaele Roma Roma

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary measurement of cellular response evaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination 7 months
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