National Project on Vaccines, COVID-19 and Frail Patients

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.

Conditions

• COVID-19
• Solid Tumor
• Hematologic Diseases
• Neurologic Disorder
• Rheumatic Diseases

Interventions

BIOLOGICAL

COVID-19 vaccines

This is an observational prospective study whose general objective is to assess the impact of COVID-19 vaccination in terms of induction of humoral and cell-mediated immune responses in selected fragile (altered immunocompetence) populations.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  collaborator OTHER

• Istituto Clinico Humanitas

  collaborator OTHER

• IRCCS San Raffaele

  collaborator OTHER

• Regina Elena Cancer Institute

  collaborator OTHER

• Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS

  collaborator NETWORK

• University of Roma La Sapienza

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Istituti Fisioterapici Ospitalieri

  collaborator OTHER

• Istituto Tumori Giovanni Paolo II, BARI

  collaborator UNKNOWN

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

  collaborator OTHER

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• Azienda USL Reggio Emilia - IRCCS

  lead OTHER_GOV

Principal Investigators

• Carlo Salvarani · Azienda USL - IRCCS di Reggio Emilia

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-19

Primary Completion

2022-05-16

Completion

2022-12-31

Countries

• Italy

Study Locations