Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463119
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-27
Brief Title:
Registry of Vaccine Responses in Immune Compromised Patients
Sponsor:
Laure Pittet MD-PhD
Organization:
Pediatric Clinical Research Platform
Study Overview
Official Title:
Registry of Vaccine Responses in Immune Compromised Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVAPI
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None