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Spots Global Cancer Trial Database for National Project on Vaccines, COVID-19 and Frail Patients

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Interventions

COVID-19 vaccines

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Massimo Costantini

Affiliation: Azienda USL - IRCCS di Reggio Emilia

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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