National Project on Vaccines, COVID-19 and Frail Patients

Completed

• Conditions: Hematologic Diseases; Solid Tumor; COVID-19; Neurologic Disorder; Rheumatic Diseases
• Interventions: Biological: COVID-19 vaccines

• Registration Number: NCT04848493
• Lead Sponsor: Azienda USL Reggio Emilia - IRCCS

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.

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-16
• Study Start: 2021-04-19
• Study First Posted: 2021-04-19
• Primary Completion: 2022-05-16
• Study Completion: 2022-12-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 747

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NEUROLOGICAL DISEASES	COVID-19 vaccines	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)
HEMATOLOGICAL MALIGNANCIES	COVID-19 vaccines	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).
SOLID TUMORS	COVID-19 vaccines	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)
IMMUNORHEUMATOLOGICAL DISEASES	COVID-19 vaccines	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)

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 vaccine immunization	5-7 weeks after T0 for Pfizer/BioNTech vaccination; 6-8 weeks after T0 for Moderna vaccination	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.

Secondary Outcome Measures

Name	Time	Method
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	At each time point, the Spike and N-specific T-cell immunity of the 1300 enrolled subjects will be assessed and compared to that observed in a population of healthy subjects at the same time point (see controls).
immunological response in different subgroups	1 year	Subgroup analysis on the immunological response will be performed according to the clinical characteristics of the patients, the main diagnosis subgroups according to the eligibility criteria and the treatments they have received. we will compare the immune response with the different clinical characteristics of the patients
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	for each time point, the anti-S antibodies levels will be quantified and compared with the anti-S antibodies levels quantified at the same time point in a population of healthy subjects (see controls).
impact of COVID-19 vaccination on patient health status	1 weeks after frist dose and 1 week after second dose	The impact on health status will be assessed through a questionnaire compiled at T1 and T2 by the physician before the blood sampling. The questionnaire will assess the occurrence of a list of symptoms in the week after the first and second administration of the vaccine.
incidence of SARS-CoV-2 infection.	all 52 weeks	The incidence of SARS-CoV-2 infection will be assessed in terms of number and proportion of patients who during the 52 weeks. SARS-CoV-2 infection will be assessed with: positive to molecular NF swab.

Trial Locations

Locations (12)

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

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