Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination

NCT ID: NCT00804219

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-11-30

Brief Summary

The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees.

The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological deficit of a distinct patient group or if it is a antigen-specific phenomenon.

Conditions

Tick-borne Encephalitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

TBE low responder

Group Type: EXPERIMENTAL

TBE vaccination and influenza vaccination

Intervention Type: BIOLOGICAL

FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x

FSME responder

Group Type: EXPERIMENTAL

TBE vaccination and influenza vaccination

Intervention Type: BIOLOGICAL

FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x

hepatitis B non-responder

Group Type: EXPERIMENTAL

TBE vaccination and influenza vaccination

Intervention Type: BIOLOGICAL

FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x

Interventions

TBE vaccination and influenza vaccination

FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x

Intervention Type: BIOLOGICAL

Other Intervention Names

FSME-Immun ATC code: J07 BA1; Inflexal ATC code: J07 BB02

Eligibility Criteria

Inclusion Criteria

• Adults (≥18 years) of both sexes without upper age limit
• Willingness to sign written informed consent form
• Basic vaccination plus one booster (minimum) of TBE-vaccine,

Exclusion Criteria

• Age: < 18 years
• Pregnancy or breast feeding
• Prior TBE infection
• Planned surgery within 2 weeks before/after any scheduled rabies vaccination during the entire study
• Concomitant medication: systemic cortisone, immune suppressive therapy 4 weeks before or planned medication during the study
• History of autoimmune disease
• Drug addiction
• Plasma donators
• Administration of other vaccines 4 weeks before/after day 0
• Administration of immunoglobulins 6 weeks prior to any vaccination or blood donation during the entire study period
• Specific Immune Therapy (Hypo-/Desensibilization) within 14 days before and after the 2 study vaccination doses.
• History of any malignant disease 5 years prior to the study entry
• Any contraindication for the administration of the TBE- or influenza vaccine according to the manufactures information.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna

Principal Investigators

Ursula Wiedermann-Schmidt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Specific Prophylaxis and Tropical Medicine

Locations

Institute of Specific Prophylaxis and Tropical Medicine

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

EK Nr 474/2008

Identifier Type: OTHER

Identifier Source: secondary_id

FSME low-responder 1.1

Identifier Type: -

Identifier Source: org_study_id