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OpenTrials
Completed

NCT Number: NCT05102669

Spike-specific Cellular Immune Response After COVID-19 Vaccination

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Immune Response Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccination Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Roma

Roma, 00163, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • subjects that tested positive for COVID-19

Treatment and study plan

analysis of immunological response

Other

collection and analysis of SARS-CoV2 Spike specific blood cells

analysis of serum antibodies

Diagnostic Test

analysis of anti-SARS-CoV2 Spike specific antibodies

Primary outcomes

  1. measurement of cellular response

    Time frame: 7 months

    evaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Acronym: RIS-COV

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2021
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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