Application of a TBE-Vaccine in Obese Persons
Primary Purpose
Tick Borne Encephalitis
Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
FSME-IMMUN Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Tick Borne Encephalitis
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
Sites / Locations
- Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Booster vaccination
Arm Description
Intervention = one i. m. TBE booster vaccination (FSME-Immun) at visit 1.
Outcomes
Primary Outcome Measures
Humoral immunity (TBE NT)
Humoral immunity tested with TBE Neutralisation test- Neutralizing antibody titer against TBE
Secondary Outcome Measures
TBE-NT titer course
TBE-NT titer course evaluation
Cellular immune response with flow cytometry
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
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
Full Information
NCT ID
NCT04017052
First Posted
July 9, 2019
Last Updated
September 6, 2019
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04017052
Brief Title
Application of a TBE-Vaccine in Obese Persons
Official Title
Application of a TBE-Vaccine in Obese Persons
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2015 (Actual)
Primary Completion Date
February 7, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick Borne Encephalitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Booster vaccination
Arm Type
Other
Arm Description
Intervention = one i. m. TBE booster vaccination (FSME-Immun) at visit 1.
Intervention Type
Drug
Intervention Name(s)
FSME-IMMUN Vaccine
Intervention Description
Booster with TBE vaccine (i.m.) FSME Immun
Primary Outcome Measure Information:
Title
Humoral immunity (TBE NT)
Description
Humoral immunity tested with TBE Neutralisation test- Neutralizing antibody titer against TBE
Time Frame
1 month +/- 7 days after booster (v3)
Secondary Outcome Measure Information:
Title
TBE-NT titer course
Description
TBE-NT titer course evaluation
Time Frame
before booster at day 0 at all visits until 3 years after booster vaccination at V5 (36 months+/-1 month)
Title
Cellular immune response with flow cytometry
Description
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
Time Frame
evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d)
Title
Measurement of Cytokines with Luminex platform/ELISA
Description
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
Time Frame
evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Wiedermann-Schmidt, MD, PhD
Organizational Affiliation
Medical University of Vienna , ISPTM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
32528467
Citation
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.
Results Reference
derived
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Application of a TBE-Vaccine in Obese Persons
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