NCT01924208

Brief Summary

Hypotheses

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_3 healthy

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

2.9 years

First QC Date

August 10, 2013

Last Update Submit

April 20, 2016

Conditions

Healthy

Keywords

TimothyInfluenzaInterferonT cellTonsil

Outcome Measures

Primary Outcomes (1)

  • Expressions of interferon and T cell and closely related cytokines and transcription factors in tonsils.

    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.

    Up to 3 years

Study Arms (4)

Timothy

ACTIVE COMPARATOR

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 virusProcedure: Timothy + attenuated influenza virus

Live attenuated influenza virus

ACTIVE COMPARATOR

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 pretenseProcedure: Timothy + attenuated influenza virus

Timothy + attenuated influenza virus

ACTIVE COMPARATOR

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 pretenseBiological: Live attenuated influenza virus

No intervention

NO INTERVENTION

No intervention (n=60, 50:50 atopic:non-atopic).

Interventions

Timothy, Phleum pretenseBIOLOGICAL

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

Live attenuated influenza virusTimothy + attenuated influenza virus
Live attenuated influenza virusBIOLOGICAL

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

TimothyTimothy + attenuated influenza virus
Timothy + attenuated influenza virusPROCEDURE

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).

Live attenuated influenza virusTimothy

Eligibility Criteria

Age4 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Otorhinolaryngology, Satakunta Central Hospital

Pori, 28500, Finland

NOT YET RECRUITING

Department of Otorhinolaryngology, Salo Regional Hospital

Salo, 24130, Finland

RECRUITING

Department of Otorhinolaryngology, Turku University Hospital

Turku, 20521, Finland

RECRUITING

Department of Pediatrics, Turku University Hospital

Turku, 20521, Finland

RECRUITING

Related Publications (2)

  • Kucuksezer UC, Palomares O, Ruckert B, Jartti T, Puhakka T, Nandy A, Gemicioglu B, Fahrner HB, Jung A, Deniz G, Akdis CA, Akdis M. Triggering of specific Toll-like receptors and proinflammatory cytokines breaks allergen-specific T-cell tolerance in human tonsils and peripheral blood. J Allergy Clin Immunol. 2013 Mar;131(3):875-85. doi: 10.1016/j.jaci.2012.10.051. Epub 2012 Dec 23.

    PMID: 23265862BACKGROUND

  • Palomares O, Ruckert B, Jartti T, Kucuksezer UC, Puhakka T, Gomez E, Fahrner HB, Speiser A, Jung A, Kwok WW, Kalogjera L, Akdis M, Akdis CA. Induction and maintenance of allergen-specific FOXP3+ Treg cells in human tonsils as potential first-line organs of oral tolerance. J Allergy Clin Immunol. 2012 Feb;129(2):510-20, 520.e1-9. doi: 10.1016/j.jaci.2011.09.031. Epub 2011 Nov 3.

    PMID: 22051696BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuomas Jartti, M.D.

CONTACT

+358 40 7270 284tuomas.jartti@utu.fi

Varpu Elenius, M.D.

CONTACT

+358 40 5746 410varkainu@utu.fi

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 10, 2013

First Posted

August 16, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

FI(4)