Vaccine ReactionSARS-ABNCT05515081
Antibody Response and Longevity Post SARS-CoV-2 Vaccine (SARS-AB)
A study testing blood sample collection in people with Vaccine Reaction, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial summary
Longitudinal study on healthy subjects to investigate the longevity of the antibody response to the Pfizer-BioNTech COVID-19 vaccine. Venous blood samples will be collected on an outpatient basis from 400 adults at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of the vaccine. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- blood sample collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2021to 21 May 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy adult subjects included in the vaccination program carried out for hospital staff of the San Camillo and Villa Salus hospitals in Venice starting from January 2021
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-Year Prospective Study of Antibody Response and Longevity Post SARS-CoV-2 Vaccine and Their Correlation With Humoral Factors
Longitudinal study on healthy subjects to investigate the longevity of the antibody response to the Pfizer-BioNTech COVID-19 vaccine. Venous blood samples will be collected on an outpatient basis from 400 adults at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of the vaccine. In the event of the administration of a third dose, the participants already recruited will be subjected to a venous blood sample immediately before administration and subsequently at regular intervals (1, 2, 4, 6, 8 and 12 months). A laboratory serological test will be performed for each sample. The expression of humoral biomarkers will be evaluated with the Luminex methodology with the aim of identifying prognostic and predictive biomarkers of the response to the vaccine.
Read the detailed description
Subject to informed consent, participants will be asked to provide a brief history of any previous SARS-CoV-2 infections and information on serological tests already performed. Subjects will undergo an outpatient venous blood sample at the San Camillo or Villa Salus hospital at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of vaccine. Sample A will be pseudo-anonymized and the serological examination for the detection of antibodies will be carried out in the diagnostic laboratories of Villa Salus and / or in the Neurobiology laboratory of the San Camillo hospital. 5 cc of blood (sample B) will be taken separately and sent to the Neurobiology laboratory of the San Camillo hospital where they will be stored and analyzed in groups for the measurement of serum inflammation mediators (chemokines, cytokines) on a Luminex platform for analysis of a cytokine and chemokine panel (eg Cytokine \& Chemokine Convenience 34-Plex Human ProcartaPlex ™ Panel 1). In the event that among the participants already recruited (200) there are individuals inoculated with a further dose of the vaccine, they will be subjected to a venous blood sample immediately before administration and subsequently at regular intervals (1, 2, 4, 6 , 8 and 12 months). The processing of the samples will take place in the manner described above.
- Conditions
- Vaccine Reaction
- Being tested
- blood sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample collectionProcedure or surgery
blood sample colletion at regular intervals
| Study group | Role | What they receive |
|---|---|---|
| vaccinated healthy subject | Other | Procedure/Surgery: blood sample collection at regular intervals Receives: Procedure: blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titre assesssed by ELISA SARS-Cov-2 anti-RBD IgG kit
Antibody levels at the same time points are compared by stratifying the sample into two groups based on whether or not volunteers had previously contracted the virus, using parametric (e.g., paired-sample t-test) or nonparametric (e.g., Wilcoxon test) tests depending on the distribution of the data.
Measured: 12 months after 3rd dose
Secondary outcomes (1)
Cytokine measurement by ELISA test such as Cytokine & Chemokine Convenience 34-Plex Human ProcartaPlex ™
Correlation with humoral factors contributing to changes in the scale of the post-vaccination immune response will be performed with Pearson correlation test or Spearman correlation test as appropriated
Measured: 12 months after 3rd dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start21 May 2021
- Primary completion21 May 2022
- Study completion21 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515081
- Sponsor's protocol ID
- 2021.06
- Acronym
- SARS-AB
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 6 Jul 2023
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Year Prospective Study of Antibody Response and Longevity Post SARS-CoV-2 Vaccine and Their Correlation With Humoral Factors
- ClinicalTrials.gov ID
- NCT05515081
- Acronym / sponsor ID
- SARS-AB / 2021.06
- Conditions
- Vaccine Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 21 May 2022 (actual)
- Study completion
- 21 May 2023 (actual)
- First posted
- 25 Aug 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.
Longitudinal study on healthy subjects to investigate the longevity of the antibody response to the Pfizer-BioNTech COVID-19 vaccine. Venous blood samples will be collected on an outpatient basis from 400 adults at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of the vaccine. In the event of the administration of a third dose, the participants already recruited will be subjected to a venous blood sample immediately before administration and subsequently at regular intervals (1, 2, 4, 6, 8 and 12 months). A laboratory serological test will be performed for each sample. The expression of humoral biomarkers will be evaluated with the Luminex methodology with the aim of identifying prognostic and predictive biomarkers of the response to the vaccine.
Detailed description
Subject to informed consent, participants will be asked to provide a brief history of any previous SARS-CoV-2 infections and information on serological tests already performed. Subjects will undergo an outpatient venous blood sample at the San Camillo or Villa Salus hospital at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of vaccine. Sample A will be pseudo-anonymized and the serological examination for the detection of antibodies will be carried out in the diagnostic laboratories of Villa Salus and / or in the Neurobiology laboratory of the San Camillo hospital. 5 cc of blood (sample B) will be taken separately and sent to the Neurobiology laboratory of the San Camillo hospital where they will be stored and analyzed in groups for the measurement of serum inflammation mediators (chemokines, cytokines) on a Luminex platform for analysis of a cytokine and chemokine panel (eg Cytokine \& Chemokine Convenience 34-Plex Human ProcartaPlex ™ Panel 1). In the event that among the participants already recruited (200) there are individuals inoculated with a further dose of the vaccine, they will be subjected to a venous blood sample immediately before administration and subsequently at regular intervals (1, 2, 4, 6 , 8 and 12 months). The processing of the samples will take place in the manner described above.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccinated healthy subject | Other | Procedure: blood sample collectionProcedure/Surgery: blood sample collection at regular intervals |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adult subjects included in the vaccination program carried out for hospital staff of the San Camillo and Villa Salus hospitals in Venice starting from January 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 |
|---|---|---|
| blood sample collectionblood sample colletion at regular intervals | Procedure or surgery | vaccinated healthy subject |
Primary outcome
Antibody titre assesssed by ELISA SARS-Cov-2 anti-RBD IgG kit
Time frame: 12 months after 3rd dose
Antibody levels at the same time points are compared by stratifying the sample into two groups based on whether or not volunteers had previously contracted the virus, using parametric (e.g., paired-sample t-test) or nonparametric (e.g., Wilcoxon test) tests depending on the distribution of the data.
1 secondary outcome
Cytokine measurement by ELISA test such as Cytokine & Chemokine Convenience 34-Plex Human ProcartaPlex ™
Time frame: 12 months after 3rd dose
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 6 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample collection in people with Vaccine Reaction, run by IRCCS San Camillo, Venezia, Italy 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 1 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 6 Jul 2023. 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?
Antibody titre assesssed by ELISA SARS-Cov-2 anti-RBD IgG kit (time frame: 12 months after 3rd dose). 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 6 Jul 2023.