Coronavirus InfectionsNCT05276388
Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-CoV-2 Infection (COVID-19)
An observational study of Coronavirus Infections, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Establishment of a biological bank of subjects vaccinated against SARS-Cov-2 infection (COVID-BioVac) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- biological bank
- Type of treatment
- Vaccines
- How many people
- 1,100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Employees, fellows, collaborators of the San Raffaele Hospital and other subjects who will be deemed suitable
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Coronavirus Infections
- Being tested
- biological bank
- Keywords
- Biobank, SARS-CoV-2, COVID-19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological bankOther
biological bank of subjects vaccinated against SARS-CoV-2 infection
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 vaccines response
Create a Biobank to evaluate the immunogenicity of COVID-19 vaccines in terms of antibody titers
Measured: from Day 1 of first vaccination up to 1 years after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciceri Fabio, IRCCS San Raffaele
- Investigators
- Patrizia Rovere Querini, MD, Study chair, IRCCS Ospedale San RaffaeleMassimo Locatelli, MD, Study chair, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276388
- Sponsor's protocol ID
- COVID BioVAC
- Status last verified
- May 2025
- First submitted
- 7 Mar 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-Cov-2 Infection (COVID-BioVac)
- ClinicalTrials.gov ID
- NCT05276388
- Acronym / sponsor ID
- COVID BioVAC
- Conditions
- Coronavirus Infections
- Keywords
- Biobank, SARS-CoV-2, COVID-19
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Employees, fellows, collaborators of the San Raffaele Hospital and other subjects who will be deemed suitable
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological bankbiological bank of subjects vaccinated against SARS-CoV-2 infection | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrizia Rovere Querini, MD study chair
IRCCS Ospedale San Raffaele
Massimo Locatelli, MD study chair
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 vaccines response (time frame: from Day 1 of first vaccination up to 1 years after the last vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.