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NCT Number: NCT07473999

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

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.

Recruiting

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

Location status: Recruiting

Location contact

Alba Muzzi, MD

CONTACT

[email protected]

0382502268

Muzzi

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaccine prophylaxis

Biological

evaluation of safety and effectiveness of vaccines in immunocompromised patients, in terms of prevention of infections

Primary outcomes

  1. incidence of infections and mortality rate from vaccine-preventable infectious diseases

    Time frame: 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 outcomes

  1. vaccinations-related adverse events

    Time frame: up to 7 years

  2. vaccine immunocompetence

    Time frame: up to 7 years

Study contacts

Contact information is provided by the study sponsor or research team.

Alba Muzzi

CONTACT

[email protected]

0382/502268

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.