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

This study is currently recruiting participants.
Verified April 2016 by Tuomas Jartti, Turku University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01924208
First Posted: August 16, 2013
Last Update Posted: April 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: None (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 Tuomas Jartti, 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 ]
    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).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 10, 2013
First Posted: August 16, 2013
Last Update Posted: April 21, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Vaccines
Interferons
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents