Registry of Vaccine Responses in Immune Compromised Patients

Immunosuppression Clinical Trial

— REVAPI  

Official title:

Registry of Vaccine Responses in Immune Compromised Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463119
• Other study ID #: CCER 2024-00363
• Status: Recruiting
• Start date: June 2024
• Est. completion date: April 2029

Study information

• Verified date: June 2024
• Source: Pediatric Clinical Research Platform
• Contact: Laure F Pittet, MD-PhD
• Phone: 0223725481
• Email: laure.pittet[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Immune compromised patient or patient who will soon be immunocompromised

2. Informed consent as documented by signature

Exclusion Criteria:

1. 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.

2. Plan to move out of the country or have prolong absence in the next 2 months

Related Conditions & MeSH terms

• Immunosuppression

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Laure Pittet, MD-PhD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dose of vaccine required to reach seroprotection	Number of doses of vaccines required to reach seroprotection, described by vaccine type and immunocompromised state	2 months (window allowed: 1 to 3 months) after vaccination
Secondary	Number of dose of vaccine required to maintain seroprotection	Number of doses of vaccines required to reach seroprotection, described by vaccine type and immunocompromised state	5 years follow-up
Secondary	Immunogenicity of vaccine (vaccine responses) in immune compromised patients	Vaccine-induced seroprotection (defined as vaccine-specific immunoglobulin concentration above seroprotection cut-off) measured in the 1 to 3 months following vaccination. If funding is sufficient, vaccine-induced cellular response and memory cells will be quantified in a subgroup of participants. Correlation with clinical protection will be evaluated as well.	2 months (window allowed: 1 to 3 months) after vaccination
Secondary	Persistence of vaccine-induced seroprotection in immune compromised patients	Persistence of vaccine-induced seroprotection (defined as vaccine-specific immunoglobulin concentration above seroprotection cut-off) measured more than 9 months after vaccination. There may be multiple measures per patients, as these are monitored regularly in immune compromised patients. If funding is sufficient, vaccine-induced functional antibodies, cellular responses and memory cells will be quantified in a subgroup of participants. Correlation with clinical protection will be evaluated as well.	5 years follow-up
Secondary	Occurence of adverse event following vaccine administration in immune compromised patients	Occurrence and severity of local and systemic reaction measured from day 0 to day 42 after vaccination	0 to 42 days after vaccination
Secondary	Patients' acceptability of the standardized follow-up	Evaluated through satisfaction questionnaire with open questions, qualitative research	5 years follow-up