Clinical trial NCT06738082: Influenza Vaccine Elicited Immune Response in Immunocompromised Patients
Official title: Influenza Vaccine Elicited Immune Response in Immunocompromised Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Vaccine
Immunocompromised Patients
Keywords: influenza
immunocompromised
vaccination
vaccine
CAR-T
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (≥ 18 years old) patients with immunocuppression (Patients with B-cell malignancies after CAR-T cell therapy, multiple sclerosis on sphingosin-1 modulator therapy, rheumatological diseases on methotrexate therapy or people living with HIV on antiretroviral therapy) and non-immunocompromised participants as control group.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Diagnosed with rheumatological diseases on immunosuppressive therapies, or Multiple sclerosis on immune modulating therapies, or B-cell malignancies after CAR-T cell therapy, or o PLWH with CD4 cell count \>200/ul, or Non-immunocompromised individuals attending the University Clinic for Infectious Diseases to receive influenza vaccination.
* Provided written informed consent.

Exclusion Criteria:

* For People Living With HIV: untreated or ≥2 measured viral loads above 50cp/ml in preceding 6 months
* For non-immunocompromised controls: any inborn or acquired condition resulting in immunosuppression.
* Receiving B-cell depleting therapies in last 12 Months for MS, RA patients and PLWH
* Receipt of Immunoglobulin-therapy (IVIG) ≤4 months prior to the drawing of study samples
* \< 18 years old
* Lack of written informed consent

Primary outcomes:
measure: Influenza vaccine elicited humoral immune response
timeFrame: Directly before and 4-6 weeks after Influenza vaccination
Secondary outcomes:
measure: Influenza vaccine elicited microneutralisation antibody titers
timeFrame: Directly before and 4-6 weeks after Influenza vaccination
measure: Seroprotection rate after influenza vaccination
timeFrame: Directly before and 4-6 weeks after Influenza vaccination
measure: Vaccine specific T-cell response
timeFrame: Directly before and 4-6 weeks after Influenza vaccination
measure: Vaccine Reactogenicity
timeFrame: Directly before and 1 week after Influenza vaccination
measure: Baseline Immune Profile
timeFrame: Directly before Influenza vaccination (same day)
measure: Change in PBMC gene-expression profiles
timeFrame: Directly before and 1 week after Influenza vaccination
measure: Baseline Prediction Model for Vaccine Response
timeFrame: Directly before and 4-6 week after Influenza vaccination
measure: Gene-Expression Updated Prediction Model for Vaccine Response
timeFrame: Directly before , 1 week and 4-6 week after Influenza vaccination
measure: Intestinal microbiome composition of vaccine responders and non-responders
timeFrame: Directly before Influenza vaccination
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitsy Hospital Bern
Study officials:
affiliation: University Hospital Bern, Switzerland
name: Christine Thurnheer, PD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bern, Switzerland
name: Cédric Hirzel, PD, MD
role: PRINCIPAL_INVESTIGATOR
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