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Recruiting NCT06463119

Registry of Vaccine Responses in Immune Compromised Patients

Observational Immunosuppression

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: Collection of data in a registry.
Who it may be relevant to
Registry conditions: Immunosuppression. 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
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Other Collection of data in a registry
    The aim of this observational project is to document the immunogenicity and reactogenicity of vaccines given to immunocompromised patients and collect it in a registry.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • University Hospitals of Geneva — Geneva

Identifiers

NCT: NCT06463119 · CCER 2024-00363

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗