Influenza Vaccine Elicited Immune Response in Immunocompromised Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Influenza vaccine elicited humoral immune response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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.
排除标准
- •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
研究组 & 干预措施
Control Group
Non-immunocompromised controls
干预措施: Influenza vaccine (Biological)
CAR-T Cell Recipients
Patients with B-cell malignancies receiving anti-CD19 CAR T-cell therapies
干预措施: Influenza vaccine (Biological)
Rheumatological Disorders
Patients with rheumatological disorders on methothrexate treatment
干预措施: Influenza vaccine (Biological)
People living with HIV
People living with HIV on successful antiretroviral treatment
干预措施: Influenza vaccine (Biological)
Multiple Sclerosis
Patients with multiple sclerosis on treatment with sphingosine-1-phosphate-receptor-agonists
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
Influenza vaccine elicited humoral immune response
时间窗: Directly before and 4-6 weeks after Influenza vaccination
The primary endpoint is the baseline variable adjusted fold-change of influenza HAI titers in immunosuppressed patients versus non-immunocompromised controls. The sum of foldchanges of hemagglutinin inhibition assay (HAI) titers 4-6 weeks after influenza vaccination will be adjusted for age, sex and baseline HAI titers by regression analysis as these three baseline variables are reported to affect influenza vaccine responses.
次要结局
- Influenza vaccine elicited microneutralisation antibody titers(Directly before and 4-6 weeks after Influenza vaccination)
- Seroprotection rate after influenza vaccination(Directly before and 4-6 weeks after Influenza vaccination)
- Vaccine specific T-cell response(Directly before and 4-6 weeks after Influenza vaccination)
- Vaccine Reactogenicity(Directly before and 1 week after Influenza vaccination)
- Baseline Immune Profile(Directly before Influenza vaccination (same day))
- Change in PBMC gene-expression profiles(Directly before and 1 week after Influenza vaccination)
- Baseline Prediction Model for Vaccine Response(Directly before and 4-6 week after Influenza vaccination)
- Gene-Expression Updated Prediction Model for Vaccine Response(Directly before , 1 week and 4-6 week after Influenza vaccination)
- Intestinal microbiome composition of vaccine responders and non-responders(Directly before Influenza vaccination)