Tonsillar Cytokine Expression After Allergen and/or Virus Intervention

Summary

Hypotheses

1. Immunotherapy induces tolerogenic effects to allergens in T cell regulation in tonsils.
2. Influenza vaccination induces a strong interferon response and decreases Th2 response in tonsils.
3. Influenza vaccination as an adjuvant on immunotherapy induces a better response to immunotherapy.

Conditions

• Healthy

Interventions

BIOLOGICAL

Timothy, Phleum pretense

Allergen. Grazax® sublingual 75.000 SQ-T tablet (extracted from timothy, Phleum pretense), once daily until operation (ALK-Abelló, Hørsholm, Denmark) (n=30) .

BIOLOGICAL

Live attenuated influenza virus

Virus. Fluenz®, nasal live attenuated influenza vaccine, one 0.2 mL dose (MedImmune, Gaithersburg, USA) (n=60, 50:50 atopic:non-atopic).

PROCEDURE

Timothy + attenuated influenza virus

Allergen. Grazax® sublingual 75.000 SQ-T tablet (extracted from timothy, Phleum pretense), once daily until operation (ALK-Abelló, Hørsholm, Denmark) + Virus. Fluenz®, nasal live attenuated influenza vaccine, one 0.2 mL dose (MedImmune, Gaithersburg, USA) (n=30).

Sponsors & Collaborators

• Academy of Finland

  collaborator OTHER

• Juselius Foundation, Helsinki, Finland

  collaborator UNKNOWN

• Foundation for Paediatric Research, Finland

  collaborator OTHER

• EVO special government transfers, Turku, Finland

  collaborator UNKNOWN

• Turku University Hospital

  lead OTHER_GOV

Principal Investigators

• Tuomas Jartti, M.D. · Dept of Pediatrics, Turku University Hospital, Turku, Finland.

• Cezmi Akdis, M.D., prof · Swiss Institute of Allergy and Asthma Research (SIAF), University of Zürich, Christine Kühne-Center for Allergy Research and Education (CK-CARE), Davos, Switzerland.

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• Finland

Study Locations