NCT06738082

Influenza Vaccine Elicited Immune Response in Immunocompromised Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 147 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to understand how well influenza vaccines work in some individuals with weakened immune systems compared to healthy individuals. Some people, such as those with HIV, multiple sclerosis, certain cancers, or autoimmune conditions, have more severe influenza disease courses due to their medical treatments. These individuals may also respond less effectively to vaccines. By comparing immune responses to the influenza vaccine in both immunocompromised patients and healthy participants, this study aims to identify patterns in vaccine effectiveness and side effects. The goal is to find better ways to predict vaccine response in vulnerable patients and improve protection against influenza.

Detailed description

The study is a single-center, prospective cohort study evaluating influenza vaccine responses in adults with weakened immune systems compared to healthy adults. Immunocompromised participants include individuals with HIV, multiple sclerosis, rheumatological diseases, and B-cell malignancies after CAR-T cell therapy. All participants will receive a standard influenza vaccine, as recommended in Switzerland, with immune response measured through blood tests at specific time points before and after vaccination. The primary objective is to compare influenza vaccine antibody levels in immunocompromised and healthy participants to determine if immune responses are different in the former group. Secondary objectives include examining vaccine-induced immune cell activity, side effects, and the immune profile before vaccination in each patient subgroup. The study will also analyze gut microbiome differences between responders and non-responders and develop prediction models for vaccine effectiveness based on immune and demographic data. By doing so, researchers hope to enhance the understanding of how best to protect immunocompromised patients against influenza.

Conditions

• Influenza Vaccine
• Immunocompromised Patients

Interventions

Type	Name	Description
BIOLOGICAL	Influenza vaccine	Standard, commercially available, quadrivalent split-vaccine against influenza is given to all study participants.

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-12-17
• Last updated: 2025-03-26

Locations

1 site across 1 country: Switzerland