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Trial record 4 of 10 for:    Recruiting, Not yet recruiting, Available Studies | "Tonsil"

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

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ClinicalTrials.gov Identifier: NCT01924208
Recruitment Status : Recruiting
First Posted : August 16, 2013
Last Update Posted : April 21, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
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
Study Start Date : October 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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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.