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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.
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.
TBE antibody titers (NT) will be tested and titer course will be evaluated at visit 1-5.
At visit 1 und 2, isolation of PBMC (Peripheral Blood Mononuclear Cells) with Ficoll gradient will be carried out and the following tests will be performed:
Serious adverse events and adverse events will be recorded at all visits
All participants will be tested again at V5, performing TBE-Neutralisation-Test three years after the booster vaccination for analysis of longterm immunogenicity. Demographic parameters will be recorded again.
Participants who are not protected against TBE for another year, three years after the booster vaccination at V5 (NT <20), will receive a booster vaccination for free.
V1 day 0, V2 day 7+3,V3 1 month +/-7 days, V4 6 months +/-14d V5 36 months+/- 1 month V6 only if TBE NT<20
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Booster vaccination | Other | Intervention = one i. m. TBE booster vaccination (FSME-Immun) at visit 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FSME-IMMUN Vaccine | Drug | Booster with TBE vaccine (i.m.) FSME Immun |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immunity (TBE NT) | Humoral immunity tested with TBE Neutralisation test- Neutralizing antibody titer against TBE | 1 month +/- 7 days after booster (v3) |
| Measure | Description | Time Frame |
|---|---|---|
| TBE-NT titer course | TBE-NT titer course evaluation | 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 |
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main Inclusion Criteria:
main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ursula Wiedermann-Schmidt, MD, PhD | Medical University of Vienna , ISPTM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32528467 | Derived | Garner-Spitzer E, Poellabauer EM, Wagner A, Guzek A, Zwazl I, Seidl-Friedrich C, Binder CJ, Stiasny K, Kundi M, Wiedermann U. Obesity and Sex Affect the Immune Responses to Tick-Borne Encephalitis Booster Vaccination. Front Immunol. 2020 May 27;11:860. doi: 10.3389/fimmu.2020.00860. eCollection 2020. |
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| ID | Term |
|---|---|
| D004675 | Encephalitis, Tick-Borne |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| ID | Term |
|---|---|
| C547297 | FSME-IMMUN vaccine |
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Cellular immune response:
Characterisation of lymphocyte sub-population with flow cytometry: detection of CD surface markers of lymphocytes with antibody panels - CD19, CD3, IgD, IgM, IgG, IgA, CD10, CD27, CD127, CCR4, CD8, CD4, CD28, CD31, CD38, CCR7, CD45RA, CD25, CD24, CD38 und FOXP3
| evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d) |
| Measurement of Cytokines with Luminex platform/ELISA | Measurement of cytokines IL-2, IFNgamma, IL-10, TNF-alpha und IL-6 in supernatants of PBMC cultures re-stimulated with TBE antigen; duration of stimulation: 48h. Measurement with Luminex Platform/ELISA | evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d) |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D017282 | Tick-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |