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TBE Vaccination in Allergic Patients

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vaccine Responsiveness in Allergy; Vaccine Responsiveness During Allergy De-sensitization Treatment

Intervention: TBE booster vaccination (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Ursula Wiedermann, MD, PhD, Principal Investigator, Affiliation: Medical University Vienna

Overall contact:
Ursula Wiedermann, MD, PhD, Phone: 0043 1 40160, Ext: 38290, Email: ursula.wiedermann@meduniwien.ac.at


Allergic patients especially those undergoing de-sensitization treatment have an altered immune responsiveness. The investigators aim to find out whether this influences immune responses to primary and booster vaccinations.

Clinical Details

Official title: TBE Vaccination in Allergic Patients

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Humoral TBE immunity

Secondary outcome:

Cellular immune response - cytokine production

Cellular immune response - lymphocyte subpopulations

TBE titer course

Detailed description: Allergic patients generally have an altered immunologic profile (Th2 bias), and allergic individuals undergoing de-sensitization treatment display an increased production of immune supressive cytokines. The investigators measure humoral and cellular immune responses to routine vaccination (TBE booster) in allergic patients with and without de-sensitization treatment to determine whether allergy negatively influences vaccine induced immune responses and protection.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- completed primary TBE immunization + at least one booster immunization

- adults of both sexes between 18 and 60 years of age

- willingness to sign written informed consent form

Exclusion Criteria:

- age < 18 and > 60 years

- prior TBE infection

- Hepatitis A vaccination

- pregnancy and breast feeding

- acute infection on day of inclusion (day 0), body temperature >37,9°C

- concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive

therapy 4 weeks prior to or during study

- administration of other vaccines 4 weeks before/after TBE vaccination

- planned surgery within 2 weeks before/after TBE vaccination

- Start of de-sensitization and the first 4 weeks of allergen dose escalation

- any contraindication to administration of FSME-Immun® vaccine according to

manufacturer's instructions

- history of malignant disease within the last 5 years

- autoimmune diseases

- drug addictions

- plasma donors

- receipt of blood transfusions or immuno globulins within 3 month before study entry

Locations and Contacts

Ursula Wiedermann, MD, PhD, Phone: 0043 1 40160, Ext: 38290, Email: ursula.wiedermann@meduniwien.ac.at

Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine, Vienna 1090, Austria; Recruiting
Ursula Wiedermann, MD, PhD, Phone: 0043 1 40160, Ext: 38260, Email: ursula.wiedermann@meduniwien.ac.at
Ursula Wiedermann, MD, PhD, Principal Investigator
Additional Information

Starting date: September 2013
Last updated: July 28, 2015

Page last updated: August 20, 2015

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