COVID19RIS-COVNCT05102669
Spike-specific Cellular Immune Response After COVID-19 Vaccination
An observational study of COVID19 and Vaccination, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Aim of this study is to evaluate whether COVID-19 vaccination induces a persistent cellular immune response. To this aim, blood samples are taken from vaccinated individuals and not immunized subjects as a control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID19, Vaccination, Immune Response
- What is being tested?
- analysis of immunological response and analysis of serum antibodies
- Type of treatment
- Vaccines
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 12 Mar 2021to 11 Oct 2021
- 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: IRCCS San Raffaele Roma health care workers
Who may be able to join
- vaccinated and non vaccinated subjects
- subjects that never tested positive for COVID19
Who cannot join
- subjects that tested positive for COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Aim of this study is to evaluate whether COVID-19 vaccination induces a persistent cellular immune response.
To this aim, blood samples are taken from vaccinated individuals and not immunized subjects as a control group.
Cells isolated from blood samples are tested in vitro to assess the percentage of spike-specific T and B lymphocytes 1 and 7 months after a second dose of Comirnaty vaccine.
Read the detailed description
After providing written informed consent, 28 vaccinated and 25 non vaccinated subjects were included in the study. All subjects were enrolled among healthcare workers in the Research Centre of IRCCS San Raffaele Roma in Rome.
All the subjects declared that they never tested positive for COVID19. Blood and serum samples were drowned twice from vaccinated subjects: 1 and 7 months after a second dose of vaccine to evaluate T and B response to vaccine; blood was drowned once in not vaccinated subjects.
Cells were collected form peripheral blood samples, while anti-S1 IgG titre was assessed in serum.
Flow-cytometry was used to assess the percentage of circulating spike-specific T and B lymphocytes.
- Conditions
- COVID19, Vaccination, Immune Response
- Being tested
- analysis of immunological response, analysis of serum antibodies
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of immunological responseOther
collection and analysis of SARS-CoV2 Spike specific blood cells
analysis of serum antibodiesDiagnostic test
analysis of anti-SARS-CoV2 Spike specific antibodies
| Study group | Role | What they receive |
|---|---|---|
| vaccinated | COVID19 vaccinated subjects Receives: Other: analysis of immunological response; Diagnostic Test: analysis of serum antibodies | |
| non vaccinated | COVID19 non vaccinated subjects Receives: Other: analysis of immunological response |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of cellular response
evaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start12 Mar 2021
- Primary completion1 Oct 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Vitiello, PhD, Principal investigator, IRCCS San Raffaele Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102669
- Sponsor's protocol ID
- RP 20/09
- Acronym
- RIS-COV
- Status last verified
- Apr 2024
- First submitted
- 28 Oct 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spike-specific Cellular Immune Response After COVID-19 Vaccination
- ClinicalTrials.gov ID
- NCT05102669
- Acronym / sponsor ID
- RIS-COV / RP 20/09
- Conditions
- COVID19, Vaccination, Immune Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 1 Nov 2021 (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.
Aim of this study is to evaluate whether COVID-19 vaccination induces a persistent cellular immune response.
To this aim, blood samples are taken from vaccinated individuals and not immunized subjects as a control group.
Cells isolated from blood samples are tested in vitro to assess the percentage of spike-specific T and B lymphocytes 1 and 7 months after a second dose of Comirnaty vaccine.
Detailed description
After providing written informed consent, 28 vaccinated and 25 non vaccinated subjects were included in the study. All subjects were enrolled among healthcare workers in the Research Centre of IRCCS San Raffaele Roma in Rome.
All the subjects declared that they never tested positive for COVID19. Blood and serum samples were drowned twice from vaccinated subjects: 1 and 7 months after a second dose of vaccine to evaluate T and B response to vaccine; blood was drowned once in not vaccinated subjects.
Cells were collected form peripheral blood samples, while anti-S1 IgG titre was assessed in serum.
Flow-cytometry was used to assess the percentage of circulating spike-specific T and B lymphocytes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccinated | – | Other: analysis of immunological response, Diagnostic Test: analysis of serum antibodiesCOVID19 vaccinated subjects |
| non vaccinated | – | Other: analysis of immunological responseCOVID19 non vaccinated subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IRCCS San Raffaele Roma health care workers
Key inclusion criteria (2 listed)
- vaccinated and non vaccinated subjects
- subjects that never tested positive for COVID19
Key exclusion criteria (1 listed)
- subjects that tested positive for COVID-19
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 |
|---|---|---|
| analysis of immunological responsecollection and analysis of SARS-CoV2 Spike specific blood cells | Other | non vaccinated, vaccinated |
| analysis of serum antibodiesanalysis of anti-SARS-CoV2 Spike specific antibodies | Diagnostic test | vaccinated |
Primary outcome
measurement of cellular response
Time frame: 7 months
evaluation of the increase of Spike-specific B and T cells percentage after COVID-19 vaccination
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 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Laura Vitiello, PhD principal investigator
IRCCS San Raffaele Roma
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 COVID19 and Vaccination, run by IRCCS San Raffaele Roma 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 2 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: finished, as of the sponsor's last update on 10 Apr 2024. 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?
measurement of cellular response (time frame: 7 months). 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 10 Apr 2024.