NCT05102669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

October 28, 2021

Last Update Submit

April 9, 2024

Conditions

COVID19VaccinationImmune Response

Outcome Measures

Primary Outcomes (1)

  • measurement of cellular response

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

    7 months

Study Arms (2)

vaccinated

COVID19 vaccinated subjects

Other: analysis of immunological responseDiagnostic Test: analysis of serum antibodies

non vaccinated

COVID19 non vaccinated subjects

Other: analysis of immunological response

Interventions

analysis of immunological responseOTHER

collection and analysis of SARS-CoV2 Spike specific blood cells

non vaccinatedvaccinated
analysis of serum antibodiesDIAGNOSTIC_TEST

analysis of anti-SARS-CoV2 Spike specific antibodies

vaccinated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IRCCS San Raffaele Roma health care workers

You may qualify if:

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

You may not qualify if:

  • subjects that tested positive for COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Roma

Roma, 00163, Italy

Location

Biospecimen

Retention: NONE RETAINED

whole blood samples and serum samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Laura Vitiello, PhD

    IRCCS San Raffaele Roma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 1, 2021

Study Start

March 12, 2021

Primary Completion

October 1, 2021

Study Completion

October 11, 2021

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

IT(1)