Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups. - Trial NCT06300853
Access comprehensive clinical trial information for NCT06300853 through Pure Global AI's free database. This phase not specified trial is sponsored by IRCCS Sacro Cuore Don Calabria di Negrar and is currently Recruiting. The study focuses on COVID-19. Target enrollment is 350 participants.
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Study Focus
Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses
Interventional
other
Sponsor & Location
IRCCS Sacro Cuore Don Calabria di Negrar
Timeline & Enrollment
N/A
Nov 14, 2023
Nov 01, 2025
Primary Outcome
Cellular response evaluation: flow cytometry profiles (proportions of cells),Cellular response evaluation: results of T and B cells stimulation with specific peptides (continuous variables, unity of measure: Optical Density OD),Cellular response evaluation: ADCC assay (continuous variables, unity of measure: Optical Density OD),Cellular response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml),Cellular response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml),Cellular response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).,Humoral response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml),Humoral response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml),Humoral response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml).
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06300853
Non-Device Trial