Registry of Vaccine Responses in Immune Compromised Patients

NCT ID: NCT06463119

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-24
• Study Completion Date: 2029-04-30

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.

Conditions

Immunosuppression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Immunocompromised patients

Priority will be given to patients with the following disease compromising their immune system:

• Solid organ recipients
• Hematopoietic stem cell transplant recipients
• HIV
• Dysimmune disorders

• Inflammatory bowel disease
• Rheumatologic disease
• Neuro-immunological disease
• Nephrotic syndrome
• Primary immunodeficiency disorder
• Pneumological disease requiring immunosuppression (e.g. bronchiolitis obliterans)
• Oncological disease

Collection of data in a registry

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laure Pittet, MD-PhD

OTHER

Sponsor Role: lead

Responsible Party

Laure Pittet, MD-PhD

Clinical Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laure F Pittet, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Geneva

Locations

University Hospitals of Geneva

Geneva, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Laure F Pittet, MD-PhD

Role: CONTACT

laure.pittet@hcuge.ch

0223725481

Facility Contacts

Laure F Pittet, MD-PhD

Role: primary

laure.pittet@hug.ch

0795538277

Other Identifiers

CCER 2024-00363

Identifier Type: -

Identifier Source: org_study_id