The effect of allergen and virus on tonsillar cell functio

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-elective tonsillectomy with or without adenotomy according to clinicl indication
-age >4 and <30 years (controls without age limits)
-written informed consent from the study subject or his/her guardian
-FluMist/Fluenz® will be used for ages >4 and <30 years, i.e. off-label use of ages >18 and <30 years
-Grazax® and Staloral® -birch will be used for ages = 5, according to selling permit
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
-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 FluMist/Fluenz® include hypersensitivity to the active substances, to any of the excipients 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.
-Additional exclusion criteria for Staloral® -birch include hypersensitivity to any of the expicients (sodium chloride, glycerol, mannitol, purified water), serious immunodefiency, malignant diseases, unstable asthma, auto-immune diseases, oral inflammation or bleeding, or ongoing treatment with beta-blockers.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Control group in combination with the intervention group and our previous tonsil cohort will also be used for investigation of role of tissues in immune tolerance and chronicity in allergic diseases, immunomodulatory effects of respiratory viruses main focus being on human bocavirus and human rhinovirus infections, and in the search of new respiratory viruses.;Main Objective: To study the effects of sublingual grass pollen immunotherapy, sublingual birch immunotherapy and/or nasal live attenuated influenza vaccine on tonsillar T cell and interferon<br>expressions and related immunogenetics.;Primary end point(s): Primary end point is the tonsillectomy. After that the trial is over for that particular patient.;Timepoint(s) of evaluation of this end point: There's no need for a timepoint of evaluation of the end point because the trial will end in all cases to the tonsillectomy.<br>

Secondary Outcome Measures