Application of a TBE-Vaccine in Obese Persons
试验速览
- 阶段
- 4 期
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Humoral immunity (TBE NT)
研究概览
简要总结
Obese people have an altered immune responsiveness. The present study investigates whether this influences immune responses to booster vaccinations (i. e. booster vaccination with TBE vaccine "FSME Immun") and if a modification of vaccination schedules is needed.
Obese adults (BMI >30) >18 - 60 years are compared with adults with normal weight (BMI <25) concerning TBE-NT- antibody titers, TBE- NT antibody titer course and cellular immunity. Metabolic parameters and sexual hormones will be tested and compared as well.
详细描述
Obese people have an altered immune responsiveness. Studies have shown that obesity has a direct effect on the immune system and leads to immunosuppression, which leads to a susceptibility to infection.We investigate whether this influences immune responses to booster vaccinations (i. e. booster vaccination with TBE vaccine "FSME Immun") and if a modification of vaccination schedules is needed.
The investigators will test and compare the humoral and cellular immune response of obese persons (BMI>30) and persons with normal weight (BMI<25) before and after a booster with FSME Immun.
The aim of the study is to clarify if a modification of vaccination schedules or a change of booster intervals is necessary for obese people. Furthermore this study will increase our understanding of the influence of obesity on different components of the immune system, as well as on the quality and quantity of the immune responses.
At Screening (visit 1) demographic parameters (age, gender, weight, BMI, waist/hip-ratio) will be recorded and metabolic parameters (Cholesterol, Triglycerides, HDL, LDL, Apolipoproteine, Lp(a), Glucose, Fructosamin, Leptin, Leptinreceptor on T- and B-cells (PCR), Insulin, high-sensitive CRP) and sex hormones (Testosterone, Estrogen, Progesteron, FSH, LH) will be tested. At visit 3 some metabolic parameters (Cholesterol, Triglycerides, HDL, Glucose, Fructosamin, Insulin und high-sensitive CRP) will be tested again. All parameters will be compared and correlated with humoral and cellular immune responses.
Immunglobulins: IgG, IgE, IgD, IgM, IgA will be tested at visit 1-4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willingness to sign written informed consent form
- •completed primary TBE immunization and at least 1 booster vaccination
- •participants of both sexes between 18 and 60 years of age
排除标准
- •age < 18 and > 60 years
- •BMI 25-30
- •previous TBE infection
- •pregnancy or breast feeding
- •acute infection on day of inclusion (day 0) or at visit 5 (36 months), body temperature > 37,9°C
- •concomitant medications: systemic cortison therapy, chemotherapy, immunotherapy (allergy) immunsuppressive therapy 4 weeks prior or during the study
- •administration of other vaccines 4 weeks before/after day 0
- •planned surgery within 2 weeks before/after TBE booster
- •any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
- •malignant diseases within 5 years prior to the study
- •autoimmune diseases
- •kidney insufficiency, dialysis
- •drug addiction
- •plasma donor
- •receipt of blood transfusions or immunoglobulins within 3 months prior to study entry / within 3 months prior to visit 5
- •Severe disease with hospitalization or surgery 3 months before or during the study
- •participation in a clinical trial simultaneously to visit 1-4 with receipt of vaccination and/or investigational product within one month before booster
研究组 & 干预措施
Booster vaccination
Intervention = one i. m. TBE booster vaccination (FSME-Immun) at visit 1.
干预措施: FSME-IMMUN Vaccine (Drug)
结局指标
主要结局
Humoral immunity (TBE NT)
时间窗: 1 month +/- 7 days after booster (v3)
Humoral immunity tested with TBE Neutralisation test- Neutralizing antibody titer against TBE
次要结局
- TBE-NT titer course(before booster at day 0 at all visits until 3 years after booster vaccination at V5 (36 months+/-1 month))
- Cellular immune response with flow cytometry(evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d))
- Measurement of Cytokines with Luminex platform/ELISA(evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d))
研究者
Univ. Prof. Dr. Ursula Wiedermann
Head of Institute of Specific Prophylaxis and Tropical Medicine
Medical University of Vienna