Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients

NCT02269566 | Terminated Phase 1 DMC

• 1 other identifier: 20140101480
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

We will perform double-blinded placebo-controlled randomized clinical trial 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.

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Rhinoconjunctivitis Quality of Life Questionnaire

  up to 12 months after the initial treatment

Secondary Outcomes (7)

• SNOT-20

  before and 4, 12 months after the initial treatment

• Skin reactivity

  before and 4, 12 months after the initial treatment

• Serum alllergen-specific IgE level

  before and 4, 12 months after the initial treatment

• Nasal reactivity

  before and 4, 12 months after the initial treatment

• Cytokines in nasal lavage fluid

  before and 4, 12 months after the initial treatment

Study Arms (2)

Allergen extract

ACTIVE COMPARATOR

0.1 ml of allergen extracts

Drug: HollisterStier

Placebo

PLACEBO COMPARATOR

Normal saline, 0.1 ml

Drug: Normal saline

Interventions

HollisterStier DRUG

0.1 ml of 30 AU/ml for Df or Dp, 10 AU/ml for Cat hair, and/or 1:1/10 weight/volume for dog hair/dander 3 injections into an inguinal lymph node

Also known as: Allergen extracts, New Orleans, USA

Allergen extract

Normal saline DRUG

0.1 ml of normal saline 3 injections into an inguinal lymph node

Also known as: JW-pharma, Seoul, Republic of Korea

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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, immnosuppressant 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

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead
• Thermo Fisher Scientific, Inc: collaborator

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Related Publications (9)

• 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: 19001265 BACKGROUND

• Martinez-Gomez JM, Johansen P, Erdmann I, Senti G, Crameri R, Kundig TM. Intralymphatic injections as a new administration route for allergen-specific immunotherapy. Int Arch Allergy Immunol. 2009;150(1):59-65. doi: 10.1159/000210381. Epub 2009 Apr 2.

  PMID: 19339803 BACKGROUND

• 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: 19680119 BACKGROUND

• von Moos S, Kundig TM, Senti G. Novel administration routes for allergen-specific immunotherapy: a review of intralymphatic and epicutaneous allergen-specific immunotherapy. Immunol Allergy Clin North Am. 2011 May;31(2):391-406, xi. doi: 10.1016/j.iac.2011.02.012.

  PMID: 21530827 BACKGROUND

• 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: 22464647 BACKGROUND

• 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: 23374268 BACKGROUND

• 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: 24035151 BACKGROUND

• 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: 24439076 BACKGROUND

• 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: 24934402 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Division of Pulmonology and Allergy

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)