protocolSection identificationModule nctId: NCT06333275, orgStudyIdInfo id: DLF-Nr: 5564, secondaryIdInfos id: BASEC-Nr: 2023-01141, type: OTHER, domain: BASEC (Business Administration System for Ethics Committees) - Switzerland, briefTitle: Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy, acronym: IMCAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-14, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are:* Do CAR-T cell therapy recipients lose vaccine protection against common vaccine-preventable pathogens* Are current re-vaccination recommendations sufficient in restoring vaccine-protection* Is this restored vaccine-protection after CAR-T cell therapy lost faster than usual* Do clinical or immunological factors predict vaccine response after CAR-T cell therapy, conditionsModule conditions: Vaccine Immunity in CAR-T Cell Therapy Recipients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Vaccines against: Diphtheria, tetanus, pertussis, polio, haemophilus influenza type b, varicella and measles, outcomesModule primaryOutcomes measure: CAR-T cell therapy associated change in antibody levels against 5 vaccine preventable pathogens, secondaryOutcomes measure: Rate of seroprotection against tetanus 6 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against haemophilus influenza type B 6 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against hepatitis B virus 6 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against poliovirus 6 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against measles virus 12 months after CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against tetanus after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against haemophilus influenza type B after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against hepatitis B virus after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against poliovirus after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Rate of seroprotection against measles after re-vaccination following CAR-T cell therapy, secondaryOutcomes measure: Clinical predictors of vaccine elicited immune response, secondaryOutcomes measure: Immunological predictors of vaccine elicited immune response, secondaryOutcomes measure: Persistence of vaccine elicited seroprotection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Bern, status: RECRUITING, city: Bern, zip: 3010, country: Switzerland, contacts name: Lukas N Baumann, MD, role: CONTACT, phone: +41 31 66 4 30 69, email: lukas.baumann2@insel.ch, contacts name: Cédric Hirzel, PD, MD, role: CONTACT, phone: +41 31 66 4 01 17, email: cedric.hirzel@insel.ch, contacts name: Christine Thurnheer Zürcher, PD, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Cédric Hirzel, PD, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lukas N Baumann, MD, role: SUB_INVESTIGATOR, contacts name: Urban Novak, Professor, role: SUB_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False