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

Active, not recruiting

• Conditions: Coronavirus Infections

• Registration Number: NCT05276388
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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

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 Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-11
• Primary Completion: 2022-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COVID-19 vaccines response	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

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Milano, Italy