Establishment of a Biological Biobank of Subjects Vaccina... | NCT05276388

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

NCT05276388

Sponsor

IRCCS San Raffaele

Status

Active, not recruiting

Last Update Posted

May 30, 2025Actual

Enrollment

1,100Estimated

Phase

Not provided

Conditions

Coronavirus Infections

Interventions

biological bank

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Mar 31, 2026Estimated

First Submitted Date

Mar 7, 2022

First Submission Date that Met QC Criteria

Mar 10, 2022

First Posted Date

Mar 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2025

Last Update Posted Date

May 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ciceri Fabio, Principal Investigator, Professor and Head of Hematology, IRCCS San RaffaelePrincipal Investigator

Lead Sponsor

IRCCS San RaffaeleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biological bank	Other	biological bank of subjects vaccinated against SARS-CoV-2 infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrizia Rovere Querini, MD	IRCCS Ospedale San Raffaele	Study Chair
Massimo Locatelli, MD	IRCCS Ospedale San Raffaele	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Ospedale San Raffaele		Milan	Milano	20132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections
D000086382	COVID-19

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018070	Biological Specimen Banks

Ancestor Terms

ID	Term
D006268	Health Facilities
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided