SAR-CoV-2BioVAC-immunitNCT07049497
Study of Immune Response in Subjects Vaccinated Against SARS-CoV-2 Infection
An observational study of SAR-CoV-2 and Cellular Immune Response, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Twelve months after the first SARS-CoV-2 cases in Wuhan, the FDA approved the first COVID-19 vaccine (Pfizer-BioNTech). Early studies on healthcare workers showed that antibody levels, especially against the Spike protein, declined within six months, particularly in those without prior infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SAR-CoV-2, Cellular Immune Response, Antibody Response
- What is being tested?
- Evaluation of the T cell response in terms of IFN-γ measured by ELISpot
- How many people
- 127 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jun 2022to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Approximately 405 biological samples will be analyzed in the study, collected from the OSR Biobank (with protocol related to the BioVAC study approved by the Ethics Committee: 17/INT/2022). These samples were obtained from healthcare workers who completed the SARS-CoV-2 vaccination cycle between January 2020 and November 2021.
Who may be able to join
- Male and/or female sex
- Age ≥18 years
- Completion of the SARS-CoV-2 vaccination cycle with the Pfizer-BioNTech vaccine
- Informed consent for the storage of biological material at the San Raffaele Hospital Biological Resource Center (with protocol related to the BioVAC study approved by the Ethics Committee: 17/INT/2022)
- Availability of at least two aliquots of PBMC collected at the completion of the vaccination cycle and frozen at the CRB
- consent for sample collection and storage in the Biobank between 2016 and 2018
Who cannot join
- none donor group
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Retrospective Observational Study on Immune Response in Biological Samples Belonging to Subjects Vaccinated Against SARS-CoV-2 Infection
Twelve months after the first SARS-CoV-2 cases in Wuhan, the FDA approved the first COVID-19 vaccine (Pfizer-BioNTech). Early studies on healthcare workers showed that antibody levels, especially against the Spike protein, declined within six months, particularly in those without prior infection. However, previously infected individuals had stronger and longer-lasting responses. The vaccine induces a Th1-type T cell response, linked to milder disease, and activates follicular helper T cells and B cell responses, although antibody levels drop over time. Immune responses also differ by sex, with females showing stronger humoral responses. Key priorities include understanding humoral fluctuations, characterizing cellular immunity, and correlating both responses.
- Conditions
- SAR-CoV-2, Cellular Immune Response, Antibody Response
- Being tested
- Evaluation of the T cell response in terms of IFN-γ measured by ELISpot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the T cell response in terms of IFN-γ measured by ELISpotOther
The evaluation of the T cell response will be performed by quantifying the frequencies of SARS-CoV-2-specific T cells producing IFN-γ using an enzyme-linked immunospot assay (ELISpot), with cryopreserved PBMC collected at the designated timepoints (T0, T1, T2, T3, and T4)
| Study group | Role | What they receive |
|---|---|---|
| 107 healthcare workers who completed the vaccination cycle for SARS-CoV-2 | T cell response in terms of IFN-γ measured by ELISpot Receives: Other: Evaluation of the T cell response in terms of IFN-γ measured by ELISpot | |
| 20 healthy donors who didn't receive SARS-CoV-2 vaccination | T cell response in terms of IFN-γ measured by ELISpot Receives: Other: Evaluation of the T cell response in terms of IFN-γ measured by ELISpot |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the existence of a correlation between the antibody titer six months after the second dose and the T and B cell responses
Correlation between antibody titer, in terms of antibodies directed against the Spike protein, and T cell response, in terms of IFN-γ measured by ELISpot, as well as B cell response, in terms of frequency and phenotype, assessed six months after the second dose (T3)
Measured: Six months after the second vaccine dose, which coincides with the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start28 Jun 2022
- Primary completion20 Jul 2022
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SAR-CoV-2Studies 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
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rovere Querini Patrizia, IRCCS San Raffaele
- Investigators
- Patrizia Rovere Querini, PhD, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049497
- Sponsor's protocol ID
- BioVAC-immunity
- Acronym
- BioVAC-immunit
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 14 Jul 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 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Retrospective Observational Study on Immune Response in Biological Samples Belonging to Subjects Vaccinated Against SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT07049497
- Acronym / sponsor ID
- BioVAC-immunit / BioVAC-immunity
- Conditions
- SAR-CoV-2, Cellular Immune Response, Antibody Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 3 Jul 2025 (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.
Twelve months after the first SARS-CoV-2 cases in Wuhan, the FDA approved the first COVID-19 vaccine (Pfizer-BioNTech). Early studies on healthcare workers showed that antibody levels, especially against the Spike protein, declined within six months, particularly in those without prior infection. However, previously infected individuals had stronger and longer-lasting responses. The vaccine induces a Th1-type T cell response, linked to milder disease, and activates follicular helper T cells and B cell responses, although antibody levels drop over time. Immune responses also differ by sex, with females showing stronger humoral responses. Key priorities include understanding humoral fluctuations, characterizing cellular immunity, and correlating both responses.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 107 healthcare workers who completed the vaccination cycle for SARS-CoV-2 | – | Other: Evaluation of the T cell response in terms of IFN-γ measured by ELISpotT cell response in terms of IFN-γ measured by ELISpot |
| 20 healthy donors who didn't receive SARS-CoV-2 vaccination | – | Other: Evaluation of the T cell response in terms of IFN-γ measured by ELISpotT cell response in terms of IFN-γ measured by ELISpot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 405 biological samples will be analyzed in the study, collected from the OSR Biobank (with protocol related to the BioVAC study approved by the Ethics Committee: 17/INT/2022). These samples were obtained from healthcare workers who completed the SARS-CoV-2 vaccination cycle between January 2020 and November 2021.
Key inclusion criteria (6 listed)
- Male and/or female sex
- Age ≥18 years
- Completion of the SARS-CoV-2 vaccination cycle with the Pfizer-BioNTech vaccine
- Informed consent for the storage of biological material at the San Raffaele Hospital Biological Resource Center (with protocol related to the BioVAC study approved by the Ethics Committee: 17/INT/2022)
- Availability of at least two aliquots of PBMC collected at the completion of the vaccination cycle and frozen at the CRB
Key exclusion criteria (2 listed)
- none donor group
- 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 |
|---|---|---|
| Evaluation of the T cell response in terms of IFN-γ measured by ELISpotThe evaluation of the T cell response will be performed by quantifying the frequencies of SARS-CoV-2-specific T cells producing IFN-γ using an enzyme-linked immunospot assay (ELISpot), with cryopreserved PBMC collected at the designated timepoints (T0, T1, T2, T3, and T4) | Other | 107 healthcare workers who completed the vaccination cycle for SARS-CoV-2, 20 healthy donors who didn't receive SARS-CoV-2 vaccination |
Primary outcome
To assess the existence of a correlation between the antibody titer six months after the second dose and the T and B cell responses
Time frame: Six months after the second vaccine dose, which coincides with the time of enrollment
Correlation between antibody titer, in terms of antibodies directed against the Spike protein, and T cell response, in terms of IFN-γ measured by ELISpot, as well as B cell response, in terms of frequency and phenotype, assessed six months after the second dose (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 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, PhD, MD principal investigator
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 SAR-CoV-2 and Cellular Immune Response, 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the existence of a correlation between the antibody titer six months after the second dose and the T and B cell responses (time frame: Six months after the second vaccine dose, which coincides with the time of enrollment). 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 14 Jul 2025.