Registry of Vaccine Responses in Immune Compromised Patients (REVAPI)

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.

Study Overview

• Status: Recruiting
• Conditions: Immunosuppression
• Intervention / Treatment: Other: Collection of data in a registry

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Laure F Pittet, MD-PhD; Phone Number: 0223725481; Email: laure.pittet@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • University Hospitals of Geneva
    • Principal Investigator: Laure F Pittet, MD-PhD
    • Contact: Laure F Pittet, MD-PhD; Phone Number: 0795538277; Email: laure.pittet@hug.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 disordersInflammatory bowel diseaseRheumatologic diseaseNeuro-immunological diseaseNephrotic syndrome; Primary immunodeficiency disorder; Pneumological disease requiring immunosuppression (e.g. bronchiolitis obliterans); Oncological disease

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Patients' acceptability of the standardized follow-up	Evaluated through satisfaction questionnaire with open questions, qualitative research	5 years follow-up

Collaborators and Investigators

• Sponsor: Laure Pittet, MD-PhD
• Investigators: Principal Investigator: Laure F Pittet, MD-PhD, University Hospitals of Geneva

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Vaccine
• Other Study ID Numbers: CCER 2024-00363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No