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Application of a TBE-Vaccine in Obese Persons
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tick Borne Encephalitis | Drug: FSME-IMMUN Vaccine | Phase 4 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 73 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Application of a TBE-Vaccine in Obese Persons |
| Actual Study Start Date : | April 15, 2015 |
| Estimated Primary Completion Date : | February 7, 2020 |
| Estimated Study Completion Date : | December 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Booster vaccination
Intervention = one i. m. TBE booster vaccination (FSME-Immun) at visit 1.
|
Drug: FSME-IMMUN Vaccine
Booster with TBE vaccine (i.m.) FSME Immun
|
- Humoral immunity (TBE NT) [ Time Frame: 1 month +/- 7 days after booster (v3) ]Humoral immunity tested with TBE Neutralisation test- Neutralizing antibody titer against TBE
- TBE-NT titer course [ Time Frame: before booster at day 0 at all visits until 3 years after booster vaccination at V5 (36 months+/-1 month) ]TBE-NT titer course evaluation
- Cellular immune response with flow cytometry [ Time Frame: evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d) ]
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 [ Time Frame: evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d) ]
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
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
| Austria | |
| Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine | |
| Vienna, Austria, 1090 | |
| Principal Investigator: | Ursula Wiedermann-Schmidt, MD, PhD | Medical University of Vienna , ISPTM |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 9, 2019 | ||||
| First Posted Date ICMJE | July 12, 2019 | ||||
| Last Update Posted Date | September 10, 2019 | ||||
| Actual Study Start Date ICMJE | April 15, 2015 | ||||
| Estimated Primary Completion Date | February 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Humoral immunity (TBE NT) [ Time Frame: 1 month +/- 7 days after booster (v3) ] Humoral immunity tested with TBE Neutralisation test- Neutralizing antibody titer against TBE
|
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| Original Primary Outcome Measures ICMJE |
Humoral immunity (TBE NT) [ Time Frame: 1 month +/- 7 days after booster (v3) ] humoral immunity tested with TBE Neutralisation trest-neutralizing antibody titer against TBE
|
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Application of a TBE-Vaccine in Obese Persons | ||||
| Official Title ICMJE | 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. |
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| 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:
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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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 4 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE | Tick Borne Encephalitis | ||||
| Intervention ICMJE | Drug: FSME-IMMUN Vaccine
Booster with TBE vaccine (i.m.) FSME Immun
|
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| Study Arms ICMJE | Booster vaccination
Intervention = one i. m. TBE booster vaccination (FSME-Immun) at visit 1.
Intervention: Drug: FSME-IMMUN Vaccine
|
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| Publications * | 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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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Actual Enrollment ICMJE |
73 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 30, 2020 | ||||
| Estimated Primary Completion Date | February 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
main Inclusion Criteria:
main Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Austria | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04017052 | ||||
| Other Study ID Numbers ICMJE | TBE_obesity_1.1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Univ. Prof. Dr. Ursula Wiedermann, Medical University of Vienna | ||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Medical University of Vienna | ||||
| Verification Date | September 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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