Application of a TBE-Vaccine in Obese Persons

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Brief Title

Application of a TBE-Vaccine in Obese Persons

Official Title

Application of a TBE-Vaccine in Obese Persons

Brief Summary

      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.
    

Detailed Description

      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:

        1. Cytokine concentrations will be measured after re-stimulating the PBMC 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 lymphocyte-subpopulations with
           antibody-panels (CD surface markers: CD19, CD3, IgD, IgM, IgG, IgA, CD10, CD27, CD127,
           CCR4, CD8, CD4, CD28, CD31, CD38, CCR7, CD45RA, CD25, CD24, CD38 und FOXP3).

      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
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Humoral immunity (TBE NT)

Secondary Outcome

 TBE-NT titer course

Condition

Tick Borne Encephalitis

Intervention

FSME-IMMUN Vaccine

Study Arms / Comparison Groups

 Booster vaccination
Description:  Intervention = one i. m. TBE booster vaccination (FSME-Immun) at visit 1.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

73

Start Date

April 15, 2015

Completion Date

December 30, 2020

Primary Completion Date

February 7, 2020

Eligibility Criteria

        main Inclusion Criteria:

          -  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

        main Exclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ursula Wiedermann-Schmidt, MD, PhD, , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT04017052

Organization ID

TBE_obesity_1.1


Responsible Party

Principal Investigator

Study Sponsor

Medical University of Vienna


Study Sponsor

Ursula Wiedermann-Schmidt, MD, PhD, Principal Investigator, Medical University of Vienna , ISPTM


Verification Date

September 2019