COVID-19COVaxFragileNCT06300853
Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.
A study testing Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses in people with COVID-19, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
This is an experimental study without drug and device, non-profit, single-center. The general objective of the project is to study how the adaptive immune response evolves against SARS-CoV-2 with repeated vaccination boosters and infections also in relation to the evolution of variations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 14 Nov 2023to Nov 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age> 18 years.
- Solid tumor diagnosis [I, II, III, IV stage,].
- Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections.
- Signed informed consent.
- Age> 70 years.
- Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections.
- Signed informed consent.
Who cannot join
- Age < 18 years.
- Absence of signed informed consent.
- Elderly subjects
- Age < 70 years.
- Absence of signed informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024
Chiara Piubelli, +390456013706, chiara.piubelli@sacrocuore.it
Chiara Piubelli
About this study
Official title: Understanding Adaptive Immune Response Elicited After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.
This is an experimental study without drug and device, non-profit, single-center.
The general objective of the project is to study how the adaptive immune response evolves against SARS-CoV-2 with repeated vaccination boosters and infections also in relation to the evolution of variations. This study will be relevant to frail populations who are the main targets of repeated vaccinations. Our project will benefit from the availability of a highly cohort characterized of vaccinated people, including cancer patients and elderly people, with prospective collection of samples for an in-depth evaluation of the evolution of the immune response with repeated exposure to doses of infection or vaccine. As part of the study, analyzes will be carried out on samples of patients enrolled in a manner prospective at the oncology departments of the IRCCS (Medical Oncology, Department of Radiotherapy advanced oncology and nuclear medicine) and elderly patients residing in retirement homes of the IRCCS. Patients will also be asked for consent to store any residual samples in the Tropica DITM Biobank.
- Conditions
- COVID-19
- Being tested
- Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster dosesOther
Whole blood and serum samples will be longitudinally collected at the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1). Possible further time points will be collected within 2 years, based on the National recommended future vaccination regimens.
Biological samples will be used for the following exams:
- Cellular immunity characterization
- T- and B-cells Immunophenotype.
- Specific T-cell response.
- In vitro specific B-cells characterization.
- Antibody-dependent cellular cytotoxicity.
- Humoral response characterization
- Serology assays.
- Avidity assay.
- Neutralization assays with different SARS-CoV-2 variants.
- Presence of specific or cross-reactive antibodies for common hCoV.
- Genetic and epigenetic analysis
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Other | Adult patients with a solid tumor diagnosis [I, II, III, IV stage,] and active anti-cancer treatment or treatment discontinued for less than 6 months, followed at IRCCS Sacro Cuore - Don Calabria, Negrar (Verona), Italy will be prospectively recruited at the moment of the future booster doses administration of SARS-CoV-2 vaccine. Receives: Other: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses |
| Elderly subjects | Other | Subjects over 70 years of age who live in the nursing home in the social area at the IRCCS Sacro Cuore - Don Calabria Hospital will be prospectively recruited at the moment of the future booster doses administration of SARS-CoV-2 vaccine. Receives: Other: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular response evaluation: flow cytometry profiles (proportions of cells)
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: results of T and B cells stimulation with specific peptides (continuous variables, unity of measure: Optical Density OD)
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: ADCC assay (continuous variables, unity of measure: Optical Density OD)
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml)
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml)
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Humoral response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml)
- A b) Analysis results of , c) Analysis results of
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Humoral response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml)
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Humoral response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Secondary outcomes (2)
Neutralization assays against different human Coronavirus (hCoV).
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Whole genome sequencing analysis results
Measured: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start14 Nov 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300853
- Sponsor's protocol ID
- 2023-07
- Acronym
- COVaxFragile
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Adaptive Immune Response Elicited After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.
- ClinicalTrials.gov ID
- NCT06300853
- Acronym / sponsor ID
- COVaxFragile / 2023-07
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 8 Mar 2024 (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.
This is an experimental study without drug and device, non-profit, single-center.
The general objective of the project is to study how the adaptive immune response evolves against SARS-CoV-2 with repeated vaccination boosters and infections also in relation to the evolution of variations. This study will be relevant to frail populations who are the main targets of repeated vaccinations. Our project will benefit from the availability of a highly cohort characterized of vaccinated people, including cancer patients and elderly people, with prospective collection of samples for an in-depth evaluation of the evolution of the immune response with repeated exposure to doses of infection or vaccine. As part of the study, analyzes will be carried out on samples of patients enrolled in a manner prospective at the oncology departments of the IRCCS (Medical Oncology, Department of Radiotherapy advanced oncology and nuclear medicine) and elderly patients residing in retirement homes of the IRCCS. Patients will also be asked for consent to store any residual samples in the Tropica DITM Biobank.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | Other | Other: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster dosesAdult patients with a solid tumor diagnosis [I, II, III, IV stage,] and active anti-cancer treatment or treatment discontinued for less than 6 months, followed at IRCCS Sacro Cuore - Don Calabria, Negrar (Verona), Italy will be prospectively recruited at the moment of the future booster doses administration of SARS-CoV-2 vaccine. |
| Elderly subjects | Other | Other: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster dosesSubjects over 70 years of age who live in the nursing home in the social area at the IRCCS Sacro Cuore - Don Calabria Hospital will be prospectively recruited at the moment of the future booster doses administration of SARS-CoV-2 vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age> 18 years.
- Solid tumor diagnosis [I, II, III, IV stage,].
- Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections.
- Signed informed consent.
- Age> 70 years.
Key exclusion criteria (5 listed)
- Age < 18 years.
- Absence of signed informed consent.
- Elderly subjects
- Age < 70 years.
- Absence of signed informed consent.
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 |
|---|---|---|
| Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster dosesWhole blood and serum samples will be longitudinally collected at the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1). Possible further time points will be collected within 2 years, based on the National recommended future vaccination regimens. Biological samples will be used for the following exams: * Cellular immunity characterization * T- and B-cells Immunophenotype. * Specific T-cell response. * In vitro specific B-cells characterization. * Antibody-dependent cellular cytotoxicity. * Humoral response characterization * Serology assays. * Avidity assay. * Neutralization assays with different SARS-CoV-2 variants. * Presence of specific or cross-reactive antibodies for common hCoV. * Genetic and epigenetic analysis | Other | Cancer patients, Elderly subjects |
Primary outcome
Cellular response evaluation: flow cytometry profiles (proportions of cells)
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: results of T and B cells stimulation with specific peptides (continuous variables, unity of measure: Optical Density OD)
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: ADCC assay (continuous variables, unity of measure: Optical Density OD)
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml)
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml)
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Cellular response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Humoral response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml)
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
a) A b) Analysis results of , c) Analysis results of
Humoral response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml)
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Humoral response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
2 secondary outcomes
Neutralization assays against different human Coronavirus (hCoV).
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Whole genome sequencing analysis results
Time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses in people with COVID-19, run by IRCCS Sacro Cuore Don Calabria di Negrar 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular response evaluation: flow cytometry profiles (proportions of cells) (time frame: At the moment of the administration of the booster doses (T0) and three weeks after the booster doses (T1).). The study lists 9 primary outcomes in all. 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 8 Mar 2024.