NCT06300853

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-14
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: Italy