Allergic RhinitisPhase 1ILIT-TNCT02665754
Intralymphatic Immunotherapy for House Dust Mite, Dog, and Cat Allergy Using Tyrosine S® in Allergic Rhinitis
A Phase 1 study testing ILIT with extract of causal allergen, ILIT with normal saline and Rescue medication for allergic rhinitis in people with Allergic Rhinitis, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The investigators 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- ILIT with extract of causal allergen, ILIT with normal saline and Rescue medication for allergic rhinitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We enrolled subjects who suffered from AR, symptoms of which were provoked by Dp, Df, dog, and/or cat allergen. Concretely, two inclusion criteria should be met.
- Sensitization should be verified by skin prick test and the level of serum specific IgE measured by ImmunoCAP® (Thermo Fisher Scientific, Uppsala, Sweden).
- Subjects should complain of AR symptoms during exposure of house dust, dog and/or cat in daily life.
Who cannot join
- Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline including a case in which forced expiratory volume in 1 s (FEV1) was less than 50% of predicted value
- Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases
- Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immunosuppressant including systemic glucocorticosteroid within last 2 weeks
- AR caused by other perennial or seasonal allergen
- Prior history of allergen-specific immunotherapy
- Rejection or low compliance,
- Pregnancy or lactation
- Vulnerable volunteer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Adverse Effect of Intralymphatic Immunotherapy With Tyrosine S®, Allergen Extract for Immunotherapy, in Patients With Allergic Rhinitis Induced by House Dust Mite, Dog, and Cat Allergen
The investigators 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 (AR), using allergen extracts for allergen-specific immunotherapy (Tyrosine S, Allergy Therapeutic, West Sussex, UK).
Read the detailed description
After informed consent, subjects will be randomly assigned to ILIT group or placebo group in double-blind manner. In both group, causal allergen or placebo will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. In ILIT group, initial dose of allergen will be 1,000-fold diluted solution from maximal concentration of allergen extract for subcutaneous immunotherapy (Tyrosine S, Allergy Therapeutic, West Sussex, UK) in volume of 0.1ml. If skin is highly reactive in skin prick test, the initial dose will be 10-fold dilution from maximal concentration where diameter of wheal is less than that of histamine. After the first dose, allergen concentration will be escalated 3-fold at second dose, and 10-fold at third dose if there are no (or mild) local or systemic hypersensitivity reaction. The allergen concentration will not change at second or third dose if there is moderate local or systemic reaction. The allergen concentration will decrease by 10 or 100-fold from previous concentration or further injection will be held if there is severe local or systemic reaction after sufficient explanation and discussion with subjects.
The investigators will evaluate allergic rhinitis symptom score before and 4, 12 months after the initial treatment. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Sino-Nasal Outcome Test (SNOT-20) will be used. Visual analogue scale (VAS) of symptoms including rhinorrhea, sneezing, nasal obstruction, postnasal drip, eye/nose/ear/palate itching, dyspnea, wheezing, chest discomfort as well as urticaria, angioedema, and itching on exposed skin during exposure to causal allergen in daily life will be also evaluated. Skin prick test (SPT), intradermal test (IDT), blood sampling for serum total immunoglobulin E (IgE), allergen-specific IgE, and allergen-specific immunoglobulin G4 (IgG4), nasal lavage for Th1, Th2, and Treg cytokines, and nasal provocation test (NPT) with Df and/or Dp allergen (in subjects whose AR symptoms are provoked by Df and/or Dp) will be also performed before and 4, 12 months after the initial treatment. In addition, the investigators evaluated the change of subjects' recognition of causal allergens, their avoidance, and AIT during this study. Using VAS, subjects were requested to score the rate of agreement with "Allergen provokes allergic symptoms in daily life", "Allergen avoidance can reduce allergic symptoms", "Allergen-specific Immunotherapy (AIT) can reduce allergic symptoms", "I can pay 50,000 Korean Won (KRW)/month for allergen avoidance", "I can pay 100,000 KRW/month for allergen avoidance", "I can pay 200,000 KRW/month for allergen avoidance", "I can pay 150,000 KRW for each injection of ILIT", "I can pay 300,000 KRW for each injection of ILIT", "I can pay 600,000 KRW for each injection of ILIT" before and after SPT/IDT, after NPT, 4 months and 1 year after ILIT.
Adverse events will be recorded and graded according to Muller classification and Ring and Meissner classification.
- Conditions
- Allergic Rhinitis
- Being tested
- ILIT with extract of causal allergen, ILIT with normal saline, Rescue medication for allergic rhinitis
- Keywords
- Allergic rhinitis, Injection, intralymphatic, Immunotherapy, Dermatophagoides farinae, Dermatophagoides pteronyssinus, Dogs, Cats
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILIT with extract of causal allergenBiological
Also called Active ILIT
0.5 ml of allergen extract from D. farinae, D. pteronyssinus, cat, and/or dog for allergen specific immunotherapy (Tyrosine S, Allergy Therapeutic, UK) will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.
ILIT with normal salineBiological
Also called Placebo ILIT
0.5 ml of normal saline will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.
Rescue medication for allergic rhinitisDrug
Also called Rescue medication
Subjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with severity and frequency of allergic rhinitis symptoms according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | In active group, extract of causal allergen will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. Receives: Biological: ILIT with extract of causal allergen; Drug: Rescue medication for allergic rhinitis |
| Placebo group | Placebo comparator | In placebo group, normal saline will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. Receives: Biological: ILIT with normal saline; Drug: Rescue medication for allergic rhinitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
RQLQ
Rhinoconjunctivitis Quality of Life Questionnaires
Measured: 4 months after the day of first injection of ILIT
Secondary outcomes (17)
SNOT-20
Sinonasal Outcome Test-20
Measured: before and 4, 12 months after the day of first injection of ILIT
Allergic symptoms provoked by causal allergen in daily life
Rates scored by subjects using visual analogue scale regarding allergic symptoms provoked by causal allergen in daily life
Measured: before and 4, 12 months after the day of first injection of ILIT
Rhinitis symptom in nasal provocation test
Rhinitis symptom (visual analogue scale: 0~100) during nasal provocation test with allergen of D. farinae and/or D. pteronyssinus in subjects in whom D. farinae and/or D. pteronyssinus is causal allergen.
Measured: before and 4, 12 months after the day of first injection of ILIT
Skin reactivity in skin prick test
Mean diameters of wheal caused by 1- to 10^7- fold dilution of causal allergen in skin prick test and their allergen histamine ratio
Measured: before and 4, 12 months after the day of first injection of ILIT
Skin reactivity in intradermal test
Mean diameters of wheal caused by 10^2- to 10^7- fold dilution of causal allergen in intradermal test and their allergen saline ratio
Measured: before and 4, 12 months after the day of first injection of ILIT
Serum total IgE level
Serum total IgE level using ImmunoCAP (Thermo Fisher Scientific, Uppsala, Sweden)
Measured: before and 4, 12 months after the day of first injection of ILIT
Allergen-specific IgE for causal allergen
Allergen-specific IgE for causal allergen of D. farinae, D. pteronyssinus, cat, and/dog using ImmunoCAP (Thermo Fisher Scientific, Uppsala, Sweden)
Measured: before and 4, 12 months after the day of first injection of ILIT
Cytokines in nasal lavage fluid before and after nasal provocation test
Cytokines of Th1, Th2, and Treg immunity including interleukin-4 (IL-4), IL-5, IL-10, IL-12, IL-13, interferon-gamma (IFN-g), and tumor growth factor-beta (TGF-b) in nasal lavage fluid
Measured: before and 4, 12 months after the day of first injection of ILIT
Subjects' score (0~100) regarding agreement to "Allergen provokes allergic symptoms in daily life"
Subjects' score regarding agreement to "Allergen provokes allergic symptoms in daily life" using visual analogue scale (0~100).
Measured: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Subjects' score (0~100) regarding agreement to "Allergen avoidance can reduce allergic symptoms"
Subjects' score regarding agreement to "Allergen avoidance can reduce allergic symptoms" using visual analogue scale (0~100).
Measured: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Subjects' score (0~100) regarding agreement to "Allergen-specific immunotherapy can reduce allergic symptoms"
Subjects' score regarding agreement to "Allergen-specific immunotherapy can reduce allergic symptoms" using visual analogue scale (0~100).
Measured: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Willingness to pay for allergen avoidance
Agreement% scored by subjects using visual analogue scale to "I am willing to pay 50,000, 100,000 or 200,000 Korean Won per month for allergen avoidance"
Measured: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Willingness to pay for intralymphatic immunotherapy
Agreement% scored by subjects using visual analogue scale to "I am willing to pay 150,000, 300,000 or 600,000 Korean Won for each injection of intralymphatic immunotherapy"
Measured: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Nasal mucosal inflammation
Inflammatory cell count in nasal mucosal biopsy (/high power field, x400)
Measured: before and 4, 12 months after the day of first injection of ILIT
RQLQ
Rhinoconjunctivitis Quality of Life Questionnaires
Measured: 12 months after the day of first injection of ILIT
Nasal cavitary volume decrease in nasal provocation test
Nasal cavitary volume decrease (basal%) measured by acoustic rhinometry during nasal provocation test with allergen of D. farinae and/or D. pteronyssinus in subjects in whom D. farinae and/or D. pteronyssinus is causal allergen.
Measured: before and 4, 12 months after the day of first injection of ILIT
Allergen-specific IgG4 for causal allergen
Allergen-specific IgG4 for causal allergen of D. farinae, D. pteronyssinus, cat, and/dog using ImmunoCAP (Thermo Fisher Scientific, Uppsala, Sweden)
Measured: before and 4, 12 months after the day of first injection of ILIT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Research Foundation
- Responsible party
- Principal investigator, Sangmin Lee, MD, Gachon University Gil Medical Center
- Investigators
- Sang Min Lee, MD, PhD, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665754
- Sponsor's protocol ID
- GBIRB2016-002
- Acronym
- ILIT-T
- Status last verified
- Feb 2020
- First submitted
- 10 Jan 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy. Curr Opin Allergy Clin Immunol. 2009 Dec;9(6):537-43. doi: 10.1097/ACI.0b013e3283310ff7.
PubMed 19680119Senti 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.
PubMed 21725898Kundig 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.
PubMed 24439076Johansen P, Kundig TM. Intralymphatic immunotherapy and vaccination in mice. J Vis Exp. 2014 Feb 2;(84):e51031. doi: 10.3791/51031.
PubMed 24513675Graf N, Dinkel B, Rose H, Hothorn LA, Gerhard D, Johansen P, Kundig TM, Klimek L, Senti G. A critical appraisal of analyzing nasal provocation test results in allergen immunotherapy trials. Rhinology. 2014 Jun;52(2):137-41. doi: 10.4193/Rhino13.145.
PubMed 24932625Zaleska 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.
PubMed 24934402Senti G, Kundig TM. Intralymphatic immunotherapy. World Allergy Organ J. 2015 Mar 7;8(1):9. doi: 10.1186/s40413-014-0047-7. eCollection 2015.
PubMed 25780493Hjalmsdottir A, Wackerle-Men Y, Duda A, Kundig TM, Johansen P. Dosing intervals in intralymphatic immunotherapy. Clin Exp Allergy. 2016 Mar;46(3):504-7. doi: 10.1111/cea.12657. No abstract available.
PubMed 26470052Senti 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.
PubMed 19001265Senti 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.
PubMed 22464647Hylander 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.
PubMed 23374268Witten 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.
PubMed 24035151Patterson AM, Bonny AE, Shiels WE 2nd, Erwin EA. Three-injection intralymphatic immunotherapy in adolescents and young adults with grass pollen rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2016 Feb;116(2):168-70. doi: 10.1016/j.anai.2015.11.010. Epub 2015 Dec 17. No abstract available.
PubMed 26706294Park HJ, Kim SH, Shin YS, Park CH, Cho ES, Choi SJ, Park SH, Jung JH, Kang IG, Lee MS, Kim DW, Lee SM, Yang MS, Lee SP. Intralymphatic immunotherapy with tyrosine-adsorbed allergens: a double-blind, placebo-controlled trial. Respir Res. 2021 Jun 4;22(1):170. doi: 10.1186/s12931-021-01766-0.
PubMed 34088322
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Adverse Effect of Intralymphatic Immunotherapy With Tyrosine S®, Allergen Extract for Immunotherapy, in Patients With Allergic Rhinitis Induced by House Dust Mite, Dog, and Cat Allergen
- ClinicalTrials.gov ID
- NCT02665754
- Acronym / sponsor ID
- ILIT-T / GBIRB2016-002
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, Injection, intralymphatic, Immunotherapy, Dermatophagoides farinae, Dermatophagoides pteronyssinus, Dogs, Cats
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Korea Research Foundation
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators 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 (AR), using allergen extracts for allergen-specific immunotherapy (Tyrosine S, Allergy Therapeutic, West Sussex, UK).
Detailed description
After informed consent, subjects will be randomly assigned to ILIT group or placebo group in double-blind manner. In both group, causal allergen or placebo will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. In ILIT group, initial dose of allergen will be 1,000-fold diluted solution from maximal concentration of allergen extract for subcutaneous immunotherapy (Tyrosine S, Allergy Therapeutic, West Sussex, UK) in volume of 0.1ml. If skin is highly reactive in skin prick test, the initial dose will be 10-fold dilution from maximal concentration where diameter of wheal is less than that of histamine. After the first dose, allergen concentration will be escalated 3-fold at second dose, and 10-fold at third dose if there are no (or mild) local or systemic hypersensitivity reaction. The allergen concentration will not change at second or third dose if there is moderate local or systemic reaction. The allergen concentration will decrease by 10 or 100-fold from previous concentration or further injection will be held if there is severe local or systemic reaction after sufficient explanation and discussion with subjects.
The investigators will evaluate allergic rhinitis symptom score before and 4, 12 months after the initial treatment. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Sino-Nasal Outcome Test (SNOT-20) will be used. Visual analogue scale (VAS) of symptoms including rhinorrhea, sneezing, nasal obstruction, postnasal drip, eye/nose/ear/palate itching, dyspnea, wheezing, chest discomfort as well as urticaria, angioedema, and itching on exposed skin during exposure to causal allergen in daily life will be also evaluated. Skin prick test (SPT), intradermal test (IDT), blood sampling for serum total immunoglobulin E (IgE), allergen-specific IgE, and allergen-specific immunoglobulin G4 (IgG4), nasal lavage for Th1, Th2, and Treg cytokines, and nasal provocation test (NPT) with Df and/or Dp allergen (in subjects whose AR symptoms are provoked by Df and/or Dp) will be also performed before and 4, 12 months after the initial treatment. In addition, the investigators evaluated the change of subjects' recognition of causal allergens, their avoidance, and AIT during this study. Using VAS, subjects were requested to score the rate of agreement with "Allergen provokes allergic symptoms in daily life", "Allergen avoidance can reduce allergic symptoms", "Allergen-specific Immunotherapy (AIT) can reduce allergic symptoms", "I can pay 50,000 Korean Won (KRW)/month for allergen avoidance", "I can pay 100,000 KRW/month for allergen avoidance", "I can pay 200,000 KRW/month for allergen avoidance", "I can pay 150,000 KRW for each injection of ILIT", "I can pay 300,000 KRW for each injection of ILIT", "I can pay 600,000 KRW for each injection of ILIT" before and after SPT/IDT, after NPT, 4 months and 1 year after ILIT.
Adverse events will be recorded and graded according to Muller classification and Ring and Meissner classification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Biological: ILIT with extract of causal allergen, Drug: Rescue medication for allergic rhinitisIn active group, extract of causal allergen will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. |
| Placebo group | Placebo comparator | Biological: ILIT with normal saline, Drug: Rescue medication for allergic rhinitisIn placebo group, normal saline will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- We enrolled subjects who suffered from AR, symptoms of which were provoked by Dp, Df, dog, and/or cat allergen. Concretely, two inclusion criteria should be met.
- Sensitization should be verified by skin prick test and the level of serum specific IgE measured by ImmunoCAP® (Thermo Fisher Scientific, Uppsala, Sweden).
- Subjects should complain of AR symptoms during exposure of house dust, dog and/or cat in daily life.
Key exclusion criteria (8 listed)
- Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline including a case in which forced expiratory volume in 1 s (FEV1) was less than 50% of predicted value
- Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases
- Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immunosuppressant including systemic glucocorticosteroid within last 2 weeks
- AR caused by other perennial or seasonal allergen
- Prior history of allergen-specific immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILIT with extract of causal allergenAlso: Active ILIT0.5 ml of allergen extract from D. farinae, D. pteronyssinus, cat, and/or dog for allergen specific immunotherapy (Tyrosine S, Allergy Therapeutic, UK) will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. | Biological | Active group |
| ILIT with normal salineAlso: Placebo ILIT0.5 ml of normal saline will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. | Biological | Placebo group |
| Rescue medication for allergic rhinitisAlso: Rescue medicationSubjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with severity and frequency of allergic rhinitis symptoms according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline. | Drug | Active group, Placebo group |
Primary outcome
RQLQ
Time frame: 4 months after the day of first injection of ILIT
Rhinoconjunctivitis Quality of Life Questionnaires
17 secondary outcomes
SNOT-20
Time frame: before and 4, 12 months after the day of first injection of ILIT
Allergic symptoms provoked by causal allergen in daily life
Time frame: before and 4, 12 months after the day of first injection of ILIT
Rhinitis symptom in nasal provocation test
Time frame: before and 4, 12 months after the day of first injection of ILIT
Skin reactivity in skin prick test
Time frame: before and 4, 12 months after the day of first injection of ILIT
Skin reactivity in intradermal test
Time frame: before and 4, 12 months after the day of first injection of ILIT
Serum total IgE level
Time frame: before and 4, 12 months after the day of first injection of ILIT
Allergen-specific IgE for causal allergen
Time frame: before and 4, 12 months after the day of first injection of ILIT
Cytokines in nasal lavage fluid before and after nasal provocation test
Time frame: before and 4, 12 months after the day of first injection of ILIT
Subjects' score (0~100) regarding agreement to "Allergen provokes allergic symptoms in daily life"
Time frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Subjects' score (0~100) regarding agreement to "Allergen avoidance can reduce allergic symptoms"
Time frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Subjects' score (0~100) regarding agreement to "Allergen-specific immunotherapy can reduce allergic symptoms"
Time frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Willingness to pay for allergen avoidance
Time frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Willingness to pay for intralymphatic immunotherapy
Time frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT
Nasal mucosal inflammation
Time frame: before and 4, 12 months after the day of first injection of ILIT
RQLQ
Time frame: 12 months after the day of first injection of ILIT
Nasal cavitary volume decrease in nasal provocation test
Time frame: before and 4, 12 months after the day of first injection of ILIT
Allergen-specific IgG4 for causal allergen
Time frame: before and 4, 12 months after the day of first injection of ILIT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 19680119Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy. Curr Opin Allergy Clin Immunol. 2009 Dec;9(6):537-43. doi: 10.1097/ACI.0b013e3283310ff7.
- Background: PubMed 21725898Senti 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.
- Background: PubMed 24439076Kundig 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.
- Background: PubMed 24513675Johansen P, Kundig TM. Intralymphatic immunotherapy and vaccination in mice. J Vis Exp. 2014 Feb 2;(84):e51031. doi: 10.3791/51031.
- Background: PubMed 24932625Graf N, Dinkel B, Rose H, Hothorn LA, Gerhard D, Johansen P, Kundig TM, Klimek L, Senti G. A critical appraisal of analyzing nasal provocation test results in allergen immunotherapy trials. Rhinology. 2014 Jun;52(2):137-41. doi: 10.4193/Rhino13.145.
- Background: PubMed 24934402Zaleska 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.
- Background: PubMed 25780493Senti G, Kundig TM. Intralymphatic immunotherapy. World Allergy Organ J. 2015 Mar 7;8(1):9. doi: 10.1186/s40413-014-0047-7. eCollection 2015.
- Background: PubMed 26470052Hjalmsdottir A, Wackerle-Men Y, Duda A, Kundig TM, Johansen P. Dosing intervals in intralymphatic immunotherapy. Clin Exp Allergy. 2016 Mar;46(3):504-7. doi: 10.1111/cea.12657. No abstract available.
- Results publication: PubMed 19001265Senti 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.
- Results publication: PubMed 22464647Senti 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.
- Results publication: PubMed 23374268Hylander 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.
- Results publication: PubMed 24035151Witten 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Min Lee, MD, PhD principal investigator
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ILIT with extract of causal allergen, ILIT with normal saline and Rescue medication for allergic rhinitis in people with Allergic Rhinitis, run by Gachon University Gil Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RQLQ (time frame: 4 months after the day of first injection of ILIT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665754, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.