Clinical trial · Observational
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).
NCT04848493CI-TRIAL-00090962VAX4FRAILcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID-19 | — | UNRESOLVED | — |
| Hematologic Diseases | — | UNRESOLVED | — |
| Neurologic Disorder | — | UNRESOLVED | — |
| Rheumatic Diseases | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COVID-19 vaccines | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- HEMATOLOGICAL MALIGNANCIES
- description
- 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).
- interventionNames
- Biological: COVID-19 vaccines
- label
- SOLID TUMORS
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDi 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