Application of a TBE-Vaccine in Obese Persons

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Vaccines

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