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Application of a TBE-Vaccine in Obese Persons

2019-07-17 10:04:59 | BioPortfolio

Summary

Obese people have an altered immune responsiveness. We investigate whether this influences immune responses to booster vaccinations (in this study the Booster vaccination is 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- Titer, TBE- antibody -Titercourse and cellular immunity, metabolic parameters and sexual hormones will be tested and compared as well.

Description

Obese people have an altered immune responsiveness. We investigate whether this influences immune responses to booster vaccinations (Booster: TBE-Vaccine: FSME Immun) and if a modification of vaccination schedules is needed.

We will test and compare the humoral and cellulare immune response of obese persons (BMI>30) and persons with normal weight (BMI<25) before and after a Booster with FSME Immun (TBE vaccine) Studies have shown that obesity has a direct effect on the immune system and leads to immunosuppression, which leads to a susceptibility to infection.

The aim of this 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 Parameter (age, gender, weight, BMI, waist/hip-ratio) will be recorded, metabolic parameters (Cholesterol, Triglycerides, HDL, LDL, Apolipoproteine, Lp(a), Glucose, Fructosamin, Leptin, Leptinreceptor on T and B-Zellen (PCR), Insulin, highsensitive CRP) and Sexual hormones (Testosterone, Estrogen, Progesteron, FSH, LH) will be tested and at visit 3 some metabolic parameters Cholesterol, Triglycerides, HDL, Glucose, Fructosamin, Insulin und highsensitive CRP will be tested again.

All parameters will be compared and correlated with humoral and cellular immune response.

Immunglobuline: IgG, IgE, IgD, IgM, IgA will be tested at visit 1-4.

TBE antibody titer (NT) will be tested and titer course will be evaluated at visit 1-5

After visit 1 und 2 Isolation of PBMC (Peripheral Blood Mononuclear Cells) with Ficoll gradient

Following tests will be performed:

1. Cytokin concentration will be measured after restimulating the PBMCs with TBE-Antigen. Duration of stimulaton: 48h; Detection with Luminex platform/ELISA: IL-2, IFNgamma, IL-10, TNF-alpha und IL-6

2. flow cytometry: Characterization of different Lymphocyt-Subpopulations with Antibody-Panels (CD surface marker : CD19, CD3, IgD, IgM, IgG, IgA, CD10, CD27, CD127, CCR4, CD8, CD4, CD28, CD31, CD38, CCR7, CD45RA, CD25, CD24, CD38 und FOXP3).

Serious Adverse 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), are getting 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

Study Design

Conditions

Tick Borne Encephalitis

Intervention

FSME-IMMUN Vaccine

Location

Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
Vienna
Austria
1090

Status

Active, not recruiting

Source

Medical University of Vienna

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-17T10:04:59-0400

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