Clinical trial NCT04848493: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Solid Tumor
Hematologic Diseases
Neurologic Disorder
Rheumatic Diseases
Keywords: vaccination
COVID-19
frail patients
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Istituto Clinico Humanitas
name: IRCCS San Raffaele
name: Regina Elena Cancer Institute
name: Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
name: University of Roma La Sapienza
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Istituti Fisioterapici Ospitalieri
name: Istituto Tumori Giovanni Paolo II, BARI
name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
First posted: 2021-04-19
Enrollment: 747
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject undergoing SARS-CoV-2 vaccination can be enrolled in the study if included in at least one of the below subgroups due to the proper underlying conditions:

HEMATOLOGICAL MALIGNANCIES These subgroups have been decided considering that patients with hematological malignancies have a low immune response because of the lympholytic treatment they receive.

SOLID TUMORS (2). ANCA-associated vasculitis Interstitial lung disease (ILD) is a feature of many connective tissue diseases (CTDs), including systemic sclerosis, mixed connective tissue disease, systemic lupus erythematosus, and Sjogren syndrome, of dermatomyositis and polymyositis, and of rheumatoid arthritis.

Multiple sclerosis

Generalized Myasthenia Gravis Patients with myasthenia gravis

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 criteria: Inclusion Criteria:

* Any subject undergoing SARS-CoV-2 vaccination with Pfizer-BioNTech or Moderna vaccines may be included in the study if they belong to at least one of the subgroups listed below:

  1. Hematological tumors
  2. Solid tumors
  3. Rheumatological diseases
  4. Neurological diseases

Exclusion Criteria:

* NA

Primary outcomes:
measure: SARS-CoV-2 vaccine immunization
timeFrame: 5-7 weeks after T0 for Pfizer/BioNTech vaccination; 6-8 weeks after T0 for Moderna vaccination
Secondary outcomes:
measure: anti-S antibodies immunological response
timeFrame: at 6 times points T0 before vaccine administration, T1 before the second dose of the vaccine and at times T2, T3, T4 and T5 which correspond to 5-7 weeks (Pfizer-BioNTech) or 6-8 weeks (Moderna), 12 weeks, 24 weeks and 52 weeks after the first dose
measure: T cell immunological response
timeFrame: at 6 times points T0 before vaccine administration, T1 before the second dose of the vaccine and at times T2, T3, T4 and T5 which correspond to 5-7 weeks (Pfizer-BioNTech) or 6-8 weeks (Moderna), 12 weeks, 24 weeks and 52 weeks after the first dose
measure: immunological response in different subgroups
timeFrame: 1 year
measure: impact of COVID-19 vaccination on patient health status
timeFrame: 1 weeks after frist dose and 1 week after second dose
measure: incidence of SARS-CoV-2 infection.
timeFrame: all 52 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria
state: Bologhna
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Milano
country: Italy
facility: Foindazione IRCCS Istituto Neurologico Carlo Besta
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia
city: Roma
country: Italy
facility: IRCCS Istituto Nazionale Tumori Regina Elena
city: Roma
country: Italy
facility: IRCCS Istituto per le Malattie Infettive Lazzaro Spallanzani
city: Roma
country: Italy
facility: Istituto Dermatologico San Gallicano
Study officials:
affiliation: Azienda USL - IRCCS di Reggio Emilia
name: Carlo Salvarani
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Cosimo S, Lupo-Stanghellini MT, Costantini M, Mantegazza R, Ciceri F, Salvarani C, Zinzani PL, Mantovani A, Ciliberto G, Uccelli A, Baldanti F, Apolone G, Delcuratolo S, Morrone A, Locatelli F, Agrati C, Silvestris N. Safety of third dose of COVID-19 vaccination in frail patients: Results from the prospective Italian VAX4FRAIL study. Front Oncol. 2022 Oct 20;12:1002168. doi: 10.3389/fonc.2022.1002168. eCollection 2022.