National Project on Vaccines, COVID-19 and Frail Patients

NCT04848493 | Completed

• 1 other identifier: VAX4FRAIL study
• Study Type: observational
• Target: 747
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Keywords

vaccination; COVID-19; frail patients

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 vaccine immunization

  For assessing the immunologic response to the COVID-19 vaccination, the anti-S antibodies levels in the fragile population will be quantified at T2 and compared with the anti-S antibodies levels quantified at the same time point in a population of healthy subjects.

  5-7 weeks after T0 for Pfizer/BioNTech vaccination; 6-8 weeks after T0 for Moderna vaccination

Secondary Outcomes (5)

• anti-S antibodies immunological response

  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

• T cell immunological response

  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

• immunological response in different subgroups

  1 year

• impact of COVID-19 vaccination on patient health status

  1 weeks after frist dose and 1 week after second dose

• incidence of SARS-CoV-2 infection.

  all 52 weeks

Study Arms (4)

HEMATOLOGICAL MALIGNANCIES

1a. Newly diagnosed patients with ANY haematological malignancy requiring treatment (No.=100). 1b. Patients with ongoing treatments or with treatments completed within 6 months (chemotherapy and target therapies) other than antibodies. More specifically: patients with ongoing or completed chemotherapy (No.=50) or patients with ongoing or completed Ibrutinib (No.=50) or patients with ongoing or completed ruxolitinib (No.=50) 1c. Patients treated with anti-CD19 or CD20 or CD22 or CD30 or anti-PD1 antibodies with or without chemotherapy OR patients receiving CAR-T cells: patients treated anti-B-cell (No.=50) or patients treated anti-CD30 (No.=50) or patients treated anti-PD1 (No.=50). 1d. Patients at three months after autologous or allogeneic transplantation without active immune suppressive therapy: after autologous transplantation (No.=50) or after allogenic transplantation (No.=50).

Biological: COVID-19 vaccines

SOLID TUMORS

2a. Chemotherapy in adjuvant therapy. All patients with a diagnosis of solid tumors apart resected basal-cell or squamous-cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, and carcinoma in situ of the Breast. Under curative surgery (stage II-III) for the solid tumor or hemotherapy alone or in combination with target therapies or radiotherapy (No.=100). 2b. Chemotherapy in metastatic Disease. All patients with a diagnosis of solid tumors with Metastatic disease (stage IV), undergoing chemotherapy alone or in combination with immunotherapy or target therapy (No.=100). 2c. Immunotherapy in metastatic Disease. All patients with a diagnosis of solid tumors with Metastatic disease (stage IV), undergoing immunotherapy alone (No.=100). 2d. Target therapies in metastatic Disease. All patients with a diagnosis of solid tumors with Metastatic disease (stage IV), Undergoing target therapy alone (No.=100)

Biological: COVID-19 vaccines

IMMUNORHEUMATOLOGICAL DISEASES

3a. Patients with ANCA-associated vasculitis classified according to Chapel Hill Consensus Conference nomenclature, treated with immunodepressants agents with/without glucocorticoids (No.=50) or treated with RTX with/without glucocorticoids (No.=50) 3b. Interstitial Lung Disease in Autoimmune Conditions. Patients with a diagnosis of a specific CTD, myositis or rheumatoid arthritis based on validated classification criteria, and clinically significant ILD defined as disease treated with traditional immunodepressants or rituximab and fibrotic and/or inflammatory changes on chest CT not attributable to infection, and no evidence of obstructive lung disease. Patients treated with traditional immunodepressive agents with/without glucocorticoidspatients (No.=50) or patients treated with rituximab with/without glucocorticoids (No.=50)

Biological: COVID-19 vaccines

NEUROLOGICAL DISEASES

4a. Patients with a diagnosis of multiple sclerosis, age \< 60 years with relapsing-remitting MS on Ocrelizumab (anti-CD20 monoclonal antibody) (No.=50) or with secondary/primary progressive MS on Ocrelizumab (anti-CD20 monoclonal antibody) (No.=50). 4b. Generalized Myasthenia Gravis, on immunosuppressive polytherapies or on B-cell targeted biological treatments, with lymphocytes count \< 1 cell/microliter, or with thymoma (No.=100)

Biological: COVID-19 vaccines

Interventions

COVID-19 vaccines BIOLOGICAL

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.

HEMATOLOGICAL MALIGNANCIES; IMMUNORHEUMATOLOGICAL DISEASES; NEUROLOGICAL DISEASES; SOLID TUMORS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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:
• Hematological tumors
• Solid tumors
• Rheumatological diseases
• Neurological diseases

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator
• Istituto Clinico Humanitas: collaborator
• IRCCS San Raffaele: collaborator
• Regina Elena Cancer Institute: collaborator
• Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS: collaborator
• University of Roma La Sapienza: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Istituti Fisioterapici Ospitalieri: collaborator
• Istituto Tumori Giovanni Paolo II, BARI: collaborator
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator
• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator

Study Sites (12)

IRCCS Istituto Tumori Giovanni Paolo II

Bari, Bari, Italy

Location

IRCCS Azienda Ospedaliera Universitaria

Bologna, Bologhna, Italy

Location

Ospedale Policlinico San Martino IRCCS

Genova, Genova, Italy

Location

Foindazione IRCCS Istituto Neurologico Carlo Besta

Milan, Milano, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milano, Italy

Location

IRCCS Istituto Clinico Humanitas

Milan, Milano, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Milano, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy

Location

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Reggio Emilia, 42123, Italy

Location

IRCCS Istituto Nazionale Tumori Regina Elena

Roma, Roma, Italy

Location

IRCCS Istituto per le Malattie Infettive Lazzaro Spallanzani

Roma, Roma, Italy

Location

Istituto Dermatologico San Gallicano

Roma, Roma, Italy

Location

Related Publications (1)

• 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.

  PMID: 36338743 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Anti-spike SARS-CoV-2 S1/S2 IgG (CE mark, part number 311450) * Anti-N SARS-CoV-2 IgG (CE mark, 6R86-22). * Neutralization Whole blood cell-mediated immunity assessment

MeSH Terms

Conditions

COVID-19; Hematologic Diseases; Nervous System Diseases; Rheumatic Diseases

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hemic and Lymphatic Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Carlo Salvarani

  Azienda USL - IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: April 19, 2021
• Primary Completion: May 16, 2022
• Study Completion: December 31, 2022
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

IT (12)