Vaccine Prophylaxis
Conditions
Brief summary
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.
Interventions
BIOLOGICALvaccine prophylaxis
evaluation of safety and effectiveness of vaccines in immunocompromised patients, in terms of prevention of infections
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient eligible for SOT or BMT evaluated in our hospital * Only patients undergoing SOT or BMT will be followed-up for infections
Exclusion criteria
* Already enrolled in the study * Denied informed consent * Absolute contraindication to vaccinations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of infections and mortality rate from vaccine-preventable infectious diseases | up to 7 years | 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. |
Secondary
| Measure | Time frame |
|---|---|
| vaccinations-related adverse events | up to 7 years |
| vaccine immunocompetence | up to 7 years |
Countries
Italy
Contacts
CONTACTAlba Muzzi
Outcome results
None listed