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临床试验/NCT07473999
NCT07473999招募中不适用

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

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
incidence of infections and mortality rate from vaccine-preventable infectious diseases

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Any patient eligible for SOT or BMT evaluated in our hospital
  • Only patients undergoing SOT or BMT will be followed-up for infections

排除标准

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

研究组 & 干预措施

non vaccinated immunocompromised patients

group of controls

vaccinated and immunocompromised patients

group of cases

干预措施: vaccine prophylaxis (Biological)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • vaccine immunocompetence(up to 7 years)
  • vaccinations-related adverse events(up to 7 years)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alba Muzzi

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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