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| Name | Class |
|---|---|
| Fondazione Cariplo | UNKNOWN |
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The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis.
Researchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis patients | Subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis |
| |
| Peritoneal dialysis patients | Subjects with advanced chronic kidney disease on peritoneal dialysis |
| |
| Healthy controls | Subjects without a prior history of chronic kidney disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccination | Biological | Single-dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of serological response to influenza vaccination | From enrollment to 30±3 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Titer of influenza-specific antibodies after vaccination | From enrollment to 30±3 days after vaccination | |
| Correlation between virus-specific antibody concentration after influenza vaccination and the frequency of circulating T follicular helper cell subsets |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2-specific antibody concentration after vaccination | From enrollment to 30±3 days after vaccination | |
| Correlation between virus-specific antibody concentration after SARS-CoV-2 vaccination and the frequency of circulating T follicular helper cell subsets |
Inclusion Criteria:
Exclusion Criteria:
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The study populations consist of (1) subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis, (2) subjects with advanced chronic kidney disease on peritoneal dialysis, and (3) subjects without a prior medical history of chronic kidney disease, who are eligible to receive an influenza vaccine according to standard clinical practice guidelines.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel A Podesta', MD, PhD | Contact | 0039 0255034568 | manuel.podesta@policlinico.mi.it | |
| Giuseppe Castellano, MD, PhD | Contact | giuseppe.castellano@policlinico.mi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy | ||
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Serum and peripheral blood mononuclear cells
| SARS-CoV-2 vaccine | Biological | Single-dose |
|
| From enrollment to 120±5 days after vaccination |
| Degree of antigen-specific activation of T follicular helper and B cells in vitro after influenza vaccination | From enrollment to 120±5 days after vaccination |
| Degree of polyclonal activation of T follicular helper and B cells in vitro after exposure to the serum of subjects vaccinated against influenza | From enrollment to 120±5 days after vaccination |
| Single-cell transcriptome expression in circulating T follicular helper cell subsets | From enrollment to 120±5 days after vaccination |
| From enrollment to 120±5 days after vaccination |
| Degree of antigen-specific activation of T follicular helper and B cells in vitro after SARS-CoV-2 vaccination | From enrollment to 120±5 days after vaccination |
| ASST Santi Paolo e Carlo |
| Not yet recruiting |
| Milan |
| 20142 |
| Italy |
| ASST Fatebenefratelli Sacco | Not yet recruiting | Milan | 20157 | Italy |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |