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.
Conditions
Interventions
Trade Name: FSME-Immun®
Product Name: FSME-Immun®
Pharmaceutical Form: Injection
INN or Proposed INN: J07BA01
CAS Number: 8000029-72-3
Other descriptive name: TBE VIRUS ANTIGEN
Concentration unit: µg
Sponsors
Institute of Specific Prophylaxis and Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 74 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Humoral immunity, based on TBE Neutralisationtest-Titers one month +/- 7 days after booster;Secondary Objective: TBE-titer course, cellular immune responses;Primary end point(s): Humoral immunity, based on TBE Neutralisationtest-Titers ;Timepoint(s) of evaluation of this end point: 1 month +/- 7 days after booster | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): TBE-titer course, cellular immune responses;Timepoint(s) of evaluation of this end point: TBE-titer course - titer evaluation before booster until 3 years after booster vaccination cellular immune response - evaluated before and 1 week after booster vaccination | — |
Countries
Austria
Contacts
Public ContactISPTM, Clinical Trials Information
Institute of Specific Prophylaxis and Tropical Medicine
Outcome results
None listed