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Transplantation is one of the most challenging and complex areas of modern medicine. Besides the intrinsic complexity of the surgical and medical procedures, transplantation medicine must take into account a flawless medical management before and after transplant, especially because these patients represent a high-risk group for developing infectious complications that may be vaccine-preventable, with a high mortality rate. However, there is poor evidence regarding the effectiveness of the currently available vaccines in immunocompromised patients. The aim of this study, is the development of a specific healthcare pathway for the prevention of infectious diseases for patients referred to our Hospital who are eligible for solid organ transplantation (SOT) or bone marrow transplantation (BMT), thus improving the vaccination coverage of these patients, possibly reducing infection-related mortality. All patients who will undergo SOT or BMT will be enrolled in the study. As per clinical practice, all these patients will be asked to receive currently recommended vaccinations. Prior to vaccination, there will be the assessment and characterization of B- and T-cell immune functions, in order to verify whether the immune system is able to respond to vaccines stimulation. Also, there will be the assessment of overall splenic function, through counting pitted red cells, the record of the incidence of infectious diseases for the subsequent 5 years after enrollment and the record of all episodes of transplant rejection. Finally, all adverse events and causes of non-adherence to the planned vaccination schedule will be recorded. All physicians involved in the care of these patients will receive a specific educational kit, including recommended vaccinations and booster doses. As a part of the project, physicians will also be offered an in-hospital education program, including lectures about the importance of vaccine prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccinated and immunocompromised patients | group of cases |
| |
| non vaccinated immunocompromised patients | group of controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaccine prophylaxis | Biological | evaluation of safety and effectiveness of vaccines in immunocompromised patients, in terms of prevention of infections |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of infections and mortality rate from vaccine-preventable infectious diseases | To explore the incidence of infections and mortality rate from vaccine-preventable infectious diseases (S. pneumoniae, N. meningitidis, influenza, along with their serotype, SARS-CoV-2) in the 5 years of observation, in vaccinated patients. A sample of unvaccinated patients will be used as control. | up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| vaccinations-related adverse events | up to 7 years | |
| vaccine immunocompetence | up to 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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BMT patients and SOT patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alba Muzzi | Contact | 0382/502268 | a.muzzi@smatteo.pv.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo di Pavia | Recruiting | Pavia | Lombardy | 27100 | Italy |
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