Official Title
Understanding Adaptive Immune Response Elicited After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.
Brief 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 evolvesagainst SARS-CoV-2 with repeated vaccination boosters and infections also in relation tothe evolution of variations. This study will be relevant to frail populations who are themain targets of repeated vaccinations. Our project will benefit from the availability ofa highly cohort characterized of vaccinated people, including cancer patients and elderlypeople, with prospective collection of samples for an in-depth evaluation of theevolution 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 amanner prospective at the oncology departments of the IRCCS (Medical Oncology, Departmentof Radiotherapy advanced oncology and nuclear medicine) and elderly patients residing inretirement homes of the IRCCS. Patients will also be asked for consent to store anyresidual samples in the Tropica DITM Biobank.

Detailed Description

Not Provided

Recruiting
COVID-19

Other: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses

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

Eligibility Criteria

Cancer patients

Inclusion criteria:

- 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.

Exclusion criteria

- Age < 18 years.

- Absence of signed informed consent.

Elderly subjects

Inclusion criteria:

- Age> 70 years.

- Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2
infections.

- Signed informed consent.

Exclusion criteria

- Age < 70 years.

- Absence of signed informed consent.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, Italy

Investigator: Chiara Piubelli
Contact: +390456013706
chiara.piubelli@sacrocuore.it

Not Provided

IRCCS Sacro Cuore Don Calabria di Negrar
NCT Number
MeSH Terms
COVID-19