NCT04017052

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2015

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

July 9, 2019

Last Update Submit

September 6, 2019

Conditions

Tick Borne Encephalitis

Outcome Measures

Primary Outcomes (1)

  • Humoral immunity (TBE NT)

    Humoral immunity tested with TBE Neutralisation test- Neutralizing antibody titer against TBE

    1 month +/- 7 days after booster (v3)

Secondary Outcomes (3)

  • TBE-NT titer course

    before booster at day 0 at all visits until 3 years after booster vaccination at V5 (36 months+/-1 month)

  • Cellular immune response with flow cytometry

    evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d)

  • Measurement of Cytokines with Luminex platform/ELISA

    evaluated before (V1 day 0) and 1 week after booster vaccination (V2 day 7+3d)

Study Arms (1)

Booster vaccination

OTHER

Intervention = one i. m. TBE booster vaccination (FSME-Immun) at visit 1.

Drug: FSME-IMMUN Vaccine

Interventions

FSME-IMMUN VaccineDRUG

Booster with TBE vaccine (i.m.) FSME Immun

Booster vaccination

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • age \< 18 and \> 60 years
  • BMI 25-30
  • previous TBE infection
  • pregnancy or breast feeding
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 32528467DERIVED

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

FSME-IMMUN vaccine

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Ursula Wiedermann-Schmidt, MD, PhD

    Medical University of Vienna , ISPTM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Institute of Specific Prophylaxis and Tropical Medicine

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 12, 2019

Study Start

April 15, 2015

Primary Completion

February 7, 2020

Study Completion

December 30, 2020

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

AU(1)