Tonsillar Cytokine Expression After Allergen and/or Virus Intervention (Tons2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Turku University Hospital
Sponsor:
Collaborators:
Academy of Finland
Sigrid Juselius Foundation, Helsinki, Finland
Foundation for Paediatric Research, Finland
EVO special government transfers, Turku, Finland
Information provided by (Responsible Party):
Tuomas Jartti, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01924208
First received: August 10, 2013
Last updated: October 12, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention Phase
Healthy
Biological: Timothy, Phleum pretense
Biological: Live attenuated influenza virus
Procedure: Timothy + attenuated influenza virus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: T Cell and Interferon Expression in Tonsils After Sublingual Immunotherapy and/or Nasal Live Attenuated Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Expressions of interferon and T cell and closely related cytokines and transcription factors in tonsils. [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Expressions of IFN-α, IFN-β, IFN-γ, IL-10, IL-13, IL-17, IL-28, IL-29, IL-37, TGF-β, FOXP3, GATA3, RORC2 and Tbet will be analyzed by quantitative real-time PCR.


Estimated Enrollment: 180
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Timothy
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).
Active Comparator: 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).
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) .
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).
Active Comparator: 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).
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).
No Intervention: No intervention
No intervention (n=60, 50:50 atopic:non-atopic).

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  Eligibility

Ages Eligible for Study:   4 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • elective tonsillectomy with or without adenotomy according to clinical indication
  • age >4 and <30 years
  • written informed consent from the study subject or his/her guardian
  • Fluenz® will be used for ages >4 and <30 years, i.e. off-label use of ages >18 and <30 years

Exclusion Criteria:

  • systemic anti-inflammatory medication within prior 4 weeks
  • systemic diseases affecting the immune system e.g. autoimmune diseases, immune complex diseases or immune deficiency diseases other than allergy, asthma or atopic dermatitis
  • malignancy, depression, psychiatric illness or medication; planned vaccination during the study period (vaccinations should not be given during study period)
  • forced expiratory volume in 1 second (FEV1) is under 80% of normal value or asthma is in a bad balance for those patients who would participate in the immunotherapy
  • sublingual grass pollen will not be given for children under the age of 5
  • additional exclusion criteria for Grazax® include hypersensitivity to any of the excipients (gelatin [fish source], mannitol, sodium hydroxide), inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis, patients with uncontrolled or severe asthma (in adults: FEV1 < 70% of predicted value after adequate pharmacologic treatment, in children: FEV1 < 80% of predicted value after adequate pharmacologic treatment)
  • addition exclusion criteria for Fluenz® include hypersensitivity to the active substances, to any of the excipients (sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin [porcine, Type A], arginine hydrochloride, monosodium glutamate monohydrate, gentamicin [a possible trace residue], eggs or to egg proteins [e.g. ovalbumin] and children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924208

Contacts
Contact: Tuomas Jartti, M.D. +358 40 7270 284 tuomas.jartti@utu.fi
Contact: Varpu Elenius, M.D. +358 40 5746 410 varkainu@utu.fi

Locations
Finland
Department of Otorhinolaryngology, Satakunta Central Hospital Not yet recruiting
Pori, Finland, 28500
Contact: Antti Silvoniemi, M.D.    +358 2 314 4933    antti.silvoniemi@utu.fi   
Contact: Tuomo Puhakka, M.D.    +358 2 313 0626    tuomo.puhakka@tyks.fi   
Principal Investigator: Antti Silvoniemi, M.D.         
Sub-Investigator: Kirsi Ylitalo, M.D.         
Department of Otorhinolaryngology, Salo Regional Hospital Recruiting
Salo, Finland, 24130
Contact: Antti Silvoniemi, M.D.    +358 2 314 4933    antti.silvoniemi@utu.fi   
Contact: Tuomo Puhakka, M.D.    +358 2 313 0626    tuomo.puhakka@tyks.fi   
Principal Investigator: Antti Silvoniemi, M.D.         
Department of Otorhinolaryngology, Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Tuomo Puhakka, M.D.    +358 2 313 0626    tuomo.puhakka@tyks.fi   
Contact: Antti Silvoniemi, M.D.    +358 2 314 4933    antti.silvoniemi@utu.fi   
Principal Investigator: Tuomo Puhakka, M.D.         
Sub-Investigator: Antti Silvoniemi, M.D.         
Department of Pediatrics, Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Tuomas Jartti, M.D.    +358 40 7270 284    tuomas.jartti@utu.fi   
Contact: Varpu Elenius, M.D.    +358 40 5746410    varkainu@utu.fi   
Principal Investigator: Tuomas Jartti, M.D.         
Sub-Investigator: Varpu Elenius, M.D.         
Sub-Investigator: Maria Saarinen, M.D.         
Sponsors and Collaborators
Turku University Hospital
Academy of Finland
Sigrid Juselius Foundation, Helsinki, Finland
Foundation for Paediatric Research, Finland
EVO special government transfers, Turku, Finland
Investigators
Principal Investigator: Tuomas Jartti, M.D. Dept of Pediatrics, Turku University Hospital, Turku, Finland.
Principal Investigator: 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.
  More Information

Publications:
Responsible Party: Tuomas Jartti, Dr, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01924208     History of Changes
Other Study ID Numbers: Tons2
Study First Received: August 10, 2013
Last Updated: October 12, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Turku University Hospital:
Timothy
Influenza
Interferon
T cell
Tonsil

Additional relevant MeSH terms:
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014