NCT02301884

Brief Summary

The investigators performed open-labeled pilot study which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

November 24, 2014

Last Update Submit

March 10, 2015

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • RQLQ

    Rhinoconjunctivitis Quality of Life Questionnaire

    Baseline and 4 months after the first injection

Secondary Outcomes (7)

  • SNOT-20

    Baseline and 4 months after the first injection

  • Skin reactivity

    Baseline and 4 months after the first injection

  • Serum total and allergen-specific IgE and IgG4 level

    Baseline and 4 months after the first injection

  • Nasal reactivity

    Baseline and 4 months after the first injection

  • Cytokines in nasal lavage fluid

    Baseline and 4 months after the first injection

  • +2 more secondary outcomes

Study Arms (1)

Allergen extract

EXPERIMENTAL

Causal allergen such as D. farinae (30 AU/ml), D. pteronyssinus (30 AU/ml), cat hair (10 AU/ml), dog hair/dander (1:1/10 w/v), or combination of those. Allergen extract, HollisterStier, New Orleans, USA. Intralymphatic injection in volume of 0.1 ml, three times with 4-week interval. Concentration was increased, decreased, or unchanged at 2nd or 3rd injection according to local or systemic reaction after previous injection

Biological: Allergen extract

Interventions

Allergen extractBIOLOGICAL

Causal allergen extract such as D. farinae, D. pteronyssinus, cat hair, dog hair/dander, or combination of those

Allergen extract

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Allergic rhinitis to house dust mite (Df, Dp), cat or dog
  • More than 3mm reaction at skin prick test for Df, Dp, cat or dog or more than class 3 at serum specific IgE level (UNICAP or MAST)

You may not qualify if:

  • Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline
  • FEV1 less than 50% of predicted value if there is comorbid asthma
  • Subject rejects the enrollment into study
  • Low compliance
  • Pregnancy or lactation
  • Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases
  • Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immunosuppressant including systemic glucocorticosteroid (20mg or more dose of prednisolone or equivalent dose of other steroid) within last 2 weeks
  • Prior history of allergen-specific immunotherapy
  • Allergic rhinitis caused by other perennial or seasonal allergen
  • Vulnerable volunteer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Related Publications (8)

  • Zaleska A, Eiwegger T, Soyer O, van de Veen W, Rhyner C, Soyka MB, Bekpen C, Demiroz D, Treis A, Sollner S, Palomares O, Kwok WW, Rose H, Senti G, Kundig TM, Ozoren N, Jutel M, Akdis CA, Crameri R, Akdis M. Immune regulation by intralymphatic immunotherapy with modular allergen translocation MAT vaccine. Allergy. 2014 Sep;69(9):1162-70. doi: 10.1111/all.12461. Epub 2014 Jul 12.

    PMID: 24934402BACKGROUND

  • Kundig TM, Johansen P, Bachmann MF, Cardell LO, Senti G. Intralymphatic immunotherapy: time interval between injections is essential. J Allergy Clin Immunol. 2014 Mar;133(3):930-1. doi: 10.1016/j.jaci.2013.11.036. Epub 2014 Jan 15. No abstract available.

    PMID: 24439076RESULT

  • Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013 Nov;132(5):1248-1252.e5. doi: 10.1016/j.jaci.2013.07.033. Epub 2013 Sep 13. No abstract available.

    PMID: 24035151RESULT

  • Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.

    PMID: 22464647RESULT

  • Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy: from the rationale to human applications. Curr Top Microbiol Immunol. 2011;352:71-84. doi: 10.1007/82_2011_133.

    PMID: 21725898RESULT

  • Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy. Curr Opin Allergy Clin Immunol. 2009 Dec;9(6):537-43. doi: 10.1097/ACI.0b013e3283310ff7.

    PMID: 19680119RESULT

  • Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.

    PMID: 19001265RESULT

  • Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056.

    PMID: 23374268RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Allergens

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AntigensBiological Factors

Study Officials

  • Sang Min Lee, M.D., Ph.D.

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 24, 2014

First Posted

November 26, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

KR(1)