COVID-19VAX4FRAILNCT04848493

National Project on Vaccines, COVID-19 and Frail Patients

An observational study of COVID-19 and Solid Tumor, run by Azienda USL Reggio Emilia - IRCCS at 12 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19, Solid Tumor, Hematologic Diseases
What is being tested?: COVID-19 vaccines
Type of treatment: Vaccines, Injection or infusion
How many people: 747 participants
Where: 12 sitesItaly
Study dates: 19 Apr 2021to 31 Dec 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Italy12 sites

IRCCS Istituto Tumori Giovanni Paolo II
Bari, Bari
IRCCS Azienda Ospedaliera Universitaria
Bologna, Bologhna
Ospedale Policlinico San Martino IRCCS
Genova, Genova
Foindazione IRCCS Istituto Neurologico Carlo Besta
Milan, Milano
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milano
IRCCS Istituto Clinico Humanitas
Milan, Milano
IRCCS Ospedale San Raffaele
Milan, Milano
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Reggio Emilia, 42123
IRCCS Istituto Nazionale Tumori Regina Elena
Roma, Roma
IRCCS Istituto per le Malattie Infettive Lazzaro Spallanzani
Roma, Roma
Istituto Dermatologico San Gallicano
Roma, Roma

Other trials in Italy

About this study

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

Read the 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
Being tested: COVID-19 vaccines
Keywords: vaccination, COVID-19, frail patients
Medical subject headings: COVID-19, Hematologic Diseases, Nervous System Diseases, Rheumatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVID-19 vaccinesBiological
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.

Study groups in NCT04848493
Study group	Role	What they receive
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). Receives: 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) Receives: 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) Receives: 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) Receives: Biological: COVID-19 vaccines

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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).
Measured: 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 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).
Measured: 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
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
Measured: 1 year
impact of COVID-19 vaccination on patient health status
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.
Measured: 1 weeks after frist dose and 1 week after second dose
incidence of SARS-CoV-2 infection.
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.
Measured: all 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 202131 Dec 2022

First posted19 Apr 2021
Study start19 Apr 2021
Primary completion16 May 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 747 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04848493
Sponsor's protocol ID: VAX4FRAIL study
Acronym: VAX4FRAIL
Status last verified: Jun 2025
First submitted: 8 Apr 2021
Last updated: 13 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 36338743

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A National, Multicentric, Observational, Prospective Study to Assess Immune Response to COVID-19 Vaccine in Frail Patients (VAX4FRAIL).
ClinicalTrials.gov ID: NCT04848493
Acronym / sponsor ID: VAX4FRAIL / VAX4FRAIL study
Conditions: COVID-19, Solid Tumor, Hematologic Diseases, Neurologic Disorder, Rheumatic Diseases
Keywords: vaccination, COVID-19, frail patients
Study type: Observational
Recruitment status: Completed
Enrolment: 747 participants (actual)
Lead sponsor: Azienda USL Reggio Emilia - IRCCSOther government
Collaborators: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Istituto Clinico Humanitas, IRCCS San Raffaele, Regina Elena Cancer Institute, Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS, University of Roma La Sapienza, Fondazione IRCCS Policlinico San Matteo di Pavia, Istituti Fisioterapici Ospitalieri, Istituti Tumori Giovanni Paolo II, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study start: 19 Apr 2021 (actual)
Primary completion: 16 May 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 19 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The immune response to COVID-19 vaccination will be assessed at the following time points:

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
HEMATOLOGICAL MALIGNANCIES	–	Biological: COVID-19 vaccines1a. 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	–	Biological: COVID-19 vaccines2a. 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	–	Biological: COVID-19 vaccines3a. 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)
NEUROLOGICAL DISEASES	–	Biological: COVID-19 vaccines4a. 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (5 listed)

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:

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COVID-19 vaccinesThis 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.	Biological	HEMATOLOGICAL MALIGNANCIES, IMMUNORHEUMATOLOGICAL DISEASES, NEUROLOGICAL DISEASES, SOLID TUMORS

Primary outcome

SARS-CoV-2 vaccine immunization
Time frame: 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.

5 secondary outcomes

anti-S antibodies immunological response
Time frame: 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
Time frame: 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
Time frame: 1 year
impact of COVID-19 vaccination on patient health status
Time frame: 1 weeks after frist dose and 1 week after second dose
incidence of SARS-CoV-2 infection.
Time frame: all 52 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Derived from this study: PubMed 36338743Di 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carlo Salvarani principal investigator

Azienda USL Reggio Emilia - IRCCS

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Solid Tumor, run by Azienda USL Reggio Emilia - IRCCS at 12 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV-2 vaccine immunization (time frame: 5-7 weeks after T0 for Pfizer/BioNTech vaccination; 6-8 weeks after T0 for Moderna vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04848493, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.