Actively Recruiting

All Genders
NCT07473999

Factors Affecting Vaccine Prophylaxis Efficacy in Bone Marrow and Solid Organ Transplant Recipients: Impact on Infection and Mortality Rates

Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2026-03-16

200

Participants Needed

1

Research Sites

365 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Factors Affecting Vaccine Prophylaxis Efficacy in Bone Marrow and Solid Organ Transplant Recipients: Impact on Infection and Mortality Rates

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Any patient eligible for SOT or BMT evaluated in our hospital
  • Only patients undergoing SOT or BMT will be followed-up for infections
Not Eligible

You will not qualify if you...

  • Already enrolled in the study
  • Denied informed consent
  • Absolute contraindication to vaccinations

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, Italy, 27100

Actively Recruiting

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Research Team

A

Alba Muzzi

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Factors Affecting Vaccine Prophylaxis Efficacy in Bone Marrow and Solid Organ Transplant Recipients: Impact on Infection and Mortality Rates | DecenTrialz