NCT05276388

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

March 7, 2022

Last Update Submit

May 26, 2025

Conditions

Coronavirus Infections

Keywords

BiobankSARS-CoV-2COVID-19

Outcome Measures

Primary Outcomes (1)

  • COVID-19 vaccines response

    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

Interventions

biological bankOTHER

biological bank of subjects vaccinated against SARS-CoV-2 infection

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Interventions

Biological Specimen Banks

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Patrizia Rovere Querini, MD

    IRCCS Ospedale San Raffaele

    STUDY CHAIR

  • Massimo Locatelli, MD

    IRCCS Ospedale San Raffaele

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor and Head of Hematology

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 11, 2022

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

March 31, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)