Registry of Vaccine Responses in Immune Compromised Patients

NCT06463119 | Recruiting

• 1 other identifier: CCER 2024-00363
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunosuppression

Keywords

Vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of dose of vaccine required to maintain seroprotection

  5 years follow-up

• Immunogenicity of vaccine (vaccine responses) in immune compromised patients

  2 months (window allowed: 1 to 3 months) after vaccination

• Persistence of vaccine-induced seroprotection in immune compromised patients

  5 years follow-up

• Occurence of adverse event following vaccine administration in immune compromised patients

  0 to 42 days after vaccination

• Patients' acceptability of the standardized follow-up

  5 years follow-up

Study Arms (1)

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

Other: Collection of data in a registry

Interventions

Collection of data in a registry 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.

Immunocompromised patients

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Immune compromised patient or patient who will soon be immunocompromised
• Informed consent as documented by signature

You may not qualify if:

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

Sponsors & Collaborators

• Laure Pittet, MD-PhD: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Provided sufficient funding, extra blood volume may be collected from a subset of participants for an in-dept evaluation of the immune response to vaccine, to evaluate vaccine-induced cellular response and memory cells, measured in the 1 to 3 months following vaccination (short-term response) and more than 9 months after vaccination (long-term response)

Study Officials

• Laure F Pittet, MD-PhD

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure F Pittet, MD-PhD

CONTACT

0223725481; laure.pittet@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 17, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

CH (1)