Clinical trial NCT06463119: Registry of Vaccine Responses in Immune Compromised Patients
Official title: Registry of Vaccine Responses in Immune Compromised Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunosuppression
Keywords: Vaccine
Lead sponsor: Pediatric Clinical Research Platform
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

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

Primary outcomes:
measure: Number of dose of vaccine required to reach seroprotection
timeFrame: 2 months (window allowed: 1 to 3 months) after vaccination
Secondary outcomes:
measure: Number of dose of vaccine required to maintain seroprotection
timeFrame: 5 years follow-up
measure: Immunogenicity of vaccine (vaccine responses) in immune compromised patients
timeFrame: 2 months (window allowed: 1 to 3 months) after vaccination
measure: Persistence of vaccine-induced seroprotection in immune compromised patients
timeFrame: 5 years follow-up
measure: Occurence of adverse event following vaccine administration in immune compromised patients
timeFrame: 0 to 42 days after vaccination
measure: Patients' acceptability of the standardized follow-up
timeFrame: 5 years follow-up
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University Hospitals of Geneva
name: Laure F Pittet, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: