Status:
UNKNOWN
Application of a TBE-Vaccine in Obese Persons
Lead Sponsor:
Medical University of Vienna
Conditions:
Tick Borne Encephalitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 Im...
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 infectio...
Eligibility Criteria
Inclusion
- main
- 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
- 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
Key Trial Info
Start Date :
April 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04017052
Start Date
April 15 2015
End Date
December 30 2020
Last Update
September 10 2019
Active Locations (1)
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1
Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
Vienna, Austria, 1090