Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-CoV-2 Infection (COVID-19)

May 26, 2025 updated by: Ciceri Fabio, IRCCS San Raffaele

Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-Cov-2 Infection (COVID-BioVac)

Establishment of a biological bank of subjects vaccinated against SARS-Cov-2 infection (COVID-BioVac)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of the COVID-BioVac study is to establish a biobank of biological samples from subjects who have received the anti-SARS-CoV-2 vaccine, with the ultimate aim (following approval by the EC of specific substudies) to study and characterize the antiviral immune response generated following anti-SARS-CoV-2 vaccination. To this end, the COVID-BioVac Biobank will be officially established for the collection and storage of human biological material, non-profit, to support research activities aimed at advancing scientific knowledge, including in the genetic field, on the immune response. vaccination-induced anti-SARS-CoV-2.

Study Type

Observational

Enrollment (Estimated)

1100

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
    • Milano
      • Milan, Milano, Italy, 20132
        • Irccs Ospedale San Raffaele

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

Employees, fellows, collaborators of the San Raffaele Hospital and other subjects who will be deemed suitable

Description

Inclusion Criteria:

  • Age ≥18 years
  • Who have vaccinated for SARS-CoV-2 with Pfizer-BioNTech vaccine or others
  • Signing of informed consent from January to March 2021

Exclusion Criteria:

  • none

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 vaccines response
Time Frame: from Day 1 of first vaccination up to 1 years after the last vaccination
Create a Biobank to evaluate the immunogenicity of COVID-19 vaccines in terms of antibody titers
from Day 1 of first vaccination up to 1 years after the last vaccination

Collaborators and Investigators

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

Sponsor

IRCCS San Raffaele

Investigators

  • Study Chair: Patrizia Rovere Querini, MD, Irccs Ospedale San Raffaele
  • Study Chair: Massimo Locatelli, MD, Irccs Ospedale San Raffaele

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)

January 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID BioVAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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