Factors Affecting Vaccine Prophylaxis Efficacy in Bone Marrow and Solid Organ Transplant Recipients: Impact on Infection and Mortality Rates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vaccine prophylaxis.
- Who it may be relevant to
- Registry conditions: Vaccine Prophylaxis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Biological vaccine prophylaxis
evaluation of safety and effectiveness of vaccines in immunocompromised patients, in terms of prevention of infections
Primary outcome measures
- incidence of infections and mortality rate from vaccine-preventable infectious diseases [Time frame: up to 7 years]
Secondary outcome measures (2)
- vaccinations-related adverse events [Time frame: up to 7 years]
- vaccine immunocompetence [Time frame: up to 7 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia
Identifiers
NCT: NCT07473999 · TRISMA