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Recruiting NCT06300853

Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.

Trial Parameters

Condition COVID-19
Sponsor IRCCS Sacro Cuore Don Calabria di Negrar
Study Type INTERVENTIONAL
Phase N/A
Enrollment 350
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-14
Completion 2025-11
Interventions
Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses

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 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.

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.

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