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临床试验/NCT06463119
NCT06463119招募中不适用

Registry of Vaccine Responses in Immune Compromised Patients

Laure Pittet, MD-PhD1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Number of dose of vaccine required to reach seroprotection

研究概览

简要总结

The aim of this project is to monitor, guide and document vaccination, vaccine responses, persistence of protection, vaccine efficacy and safety in immune compromised patients at various moment of their disease: right after the diagnosis, before the introduction of the immunosuppressive treatment, once the individual is under immunosuppressive treatment, or once immunosuppression is over.

详细描述

The aim of this project is to monitor, guide and document vaccination, vaccine responses, persistence of protection, vaccine efficacy and safety in immune compromised patients at various moment of their disease: right after the diagnosis, before the introduction of the immunosuppressive treatment, once the individual is under immunosuppressive treatment, or once immunosuppression is over. The project will not only help to optimise the vaccination status of the immunocompromised patients followed in our institution, but will enable to gather essential data on vaccine responses and the evolution of serology against vaccine-preventable diseases over time. The project will also collect essential data on vaccination with live-attenuated vaccines.

The University Hospitals of Geneva and the Centre of vaccinology of the University of Geneva are recognised worldwide for their expertise in vaccinology, particularly in immunocompromised patients. Unfortunately, the management of these patients is not yet standardised, and no data is collected, precluding its dissemination. The aim of this project is to enable to share our expertise on vaccination of immune compromised patients with other teams by standardizing our practice and creating a registry.

Although measles-mumps-rubella (MMR) and varicella-zoster virus (VZV) vaccination are recommended in selected immune compromised patients fulfilling strict safety criterion, these criteria are not standardised, and only few groups have reported on the immunogenicity and the safety of these vaccination. As a results, many healthcare providers are hesitant to administer the vaccines and call for standardized operating procedures for vaccination and follow-up that are adapted to each immunocompromised condition. In addition, there are no data on the patients' perceptions of these vaccinations.

Therefore, the objective of this project is to optimise the administration of vaccines to immunocompromised patients by providing tailored information and personalised follow-up. The project will evaluate what information the patients need before and after vaccination, and what kind of follow-up is the most appropriate for each condition. By providing a standardised clinical and serological follow-up, this project will also document the reactogenicity and the immunogenicity of vaccines, and identify whether they differ among the various immune compromised state. It will also identify in whom and for which vaccines, additional doses are required to reach protection, and in whom repeated doses are needed during follow-up to maintain protection throughout the years. The results of this project will help to improve the follow-up of immune compromised patients following vaccination, and provide tailored follow-up for each of the immune compromised condition.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Immune compromised patient or patient who will soon be immunocompromised
  • Informed consent as documented by signature

排除标准

  • Individual/parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc.
  • Plan to move out of the country or have prolong absence in the next 2 months

结局指标

主要结局

Number of dose of vaccine required to reach seroprotection

时间窗: 2 months (window allowed: 1 to 3 months) after vaccination

Number of doses of vaccines required to reach seroprotection, described by vaccine type and immunocompromised state

次要结局

  • Number of dose of vaccine required to maintain seroprotection(5 years follow-up)
  • Patients' acceptability of the standardized follow-up(5 years follow-up)
  • Immunogenicity of vaccine (vaccine responses) in immune compromised patients(2 months (window allowed: 1 to 3 months) after vaccination)
  • Persistence of vaccine-induced seroprotection in immune compromised patients(5 years follow-up)
  • Occurence of adverse event following vaccine administration in immune compromised patients(0 to 42 days after vaccination)

研究者

发起方
Laure Pittet, MD-PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Laure Pittet, MD-PhD

Clinical Scientist

Pediatric Clinical Research Platform

研究点 (1)

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