protocolSection identificationModule nctId: NCT06300853, orgStudyIdInfo id: 2023-07, briefTitle: Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups., acronym: COVaxFragile, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-14, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses, outcomesModule primaryOutcomes measure: Cellular response evaluation: flow cytometry profiles (proportions of cells), primaryOutcomes measure: Cellular response evaluation: results of T and B cells stimulation with specific peptides (continuous variables, unity of measure: Optical Density OD), primaryOutcomes measure: Cellular response evaluation: ADCC assay (continuous variables, unity of measure: Optical Density OD), primaryOutcomes measure: Cellular response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml), primaryOutcomes measure: Cellular response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml), primaryOutcomes measure: Cellular response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml)., primaryOutcomes measure: Humoral response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml), primaryOutcomes measure: Humoral response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml), primaryOutcomes measure: Humoral response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml)., secondaryOutcomes measure: Neutralization assays against different human Coronavirus (hCoV)., secondaryOutcomes measure: Whole genome sequencing analysis results, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Chiara Piubelli, role: CONTACT, phone: +390456013706, email: chiara.piubelli@sacrocuore.it, contacts name: Chiara Piubelli, role: PRINCIPAL_INVESTIGATOR, contacts name: Stefania Gori, role: SUB_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False