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NCT05276388 Clinical Trial

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

Coronavirus Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05276388
Other study ID # COVID BioVAC
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date March 31, 2023

Study information
Verified date March 2022
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1100
Est. completion date March 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• biological bank
biological bank of subjects vaccinated against SARS-CoV-2 infection

Locations
Country Name City State
Italy IRCCS Ospedale San Raffaele Milan Milano

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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