NCT06463119

Registry of Vaccine Responses in Immune Compromised Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Laure Pittet, MD-PhD · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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.

Conditions

• Immunosuppression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-24
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2024-06-17
• Last updated: 2024-11-07

Locations

1 site across 1 country: Switzerland