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Brief Title: National Project on Vaccines, COVID-19 and Frail Patients
Official Title: A National, Multicentric, Observational, Prospective Study to Assess Immune Response to COVID-19 Vaccine in Frail Patients (VAX4FRAIL).
Study ID: NCT04848493
Brief Summary: This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies.
Detailed Description: The immune response to COVID-19 vaccination will be assessed at the following time points: T0: the day of vaccination T1: the day of the booster dose according to the schedule of the two vaccines (Pfizer/BioNTech or Moderna) T2: between 5 and 7 weeks after T0 for those vaccinated with Pfizer/BioNTech and between 6 and 8 weeks after T0 for those vaccinated with Moderna. * T3: 12 (± 1) weeks after T0 * T4: 24 (± 2) weeks from T0 * T5: 52 (± 2) weeks from T0 Prevention of SARS-CoV-2 infection will be assessed in terms of incidence of SARS-CoV-2 infections (NF molecular swab positive), and of SARS-CoV-2 infections requiring hospitalisation.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
IRCCS Azienda Ospedaliera Universitaria, Bologna, Bologhna, Italy
IRCCS Istituto Tumori Giovanni Paolo II, Bari, , Italy
Ospedale Policlinico San Martino IRCCS, Genova, , Italy
Foindazione IRCCS Istituto Neurologico Carlo Besta, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IRCCS Istituto Clinico Humanitas, Milano, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, , Italy
IRCCS Istituto Nazionale Tumori Regina Elena, Roma, , Italy
IRCCS Istituto per le Malattie Infettive Lazzaro Spallanzani, Roma, , Italy
Istituto Dermatologico San Gallicano, Roma, , Italy
Name: Massimo Costantini
Affiliation: Azienda USL - IRCCS di Reggio Emilia
Role: PRINCIPAL_INVESTIGATOR