NCT04848493

National Project on Vaccines, COVID-19 and Frail Patients

A National, Multicentric, Observational, Prospective Study to Assess Immune Response to COVID-19 Vaccine in Frail Patients (VAX4FRAIL).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 747 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-19
• Primary completion: 2022-05-16
• Completion: 2022-12-31
• First posted: 2021-04-19
• Last updated: 2025-06-13

Locations

12 sites across 1 country: Italy