- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210193
Is Intralymphatic Allergen Immunotherapy Effective and Safe?
Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT.
The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires.
The first part of the study is completed and published (PMID: 23374268)
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Borås, Sweden, 501 82
- Allergy Unit, Södra Älvsborgs Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-50,
- Seasonal allergic symptoms for birch and/or grass verified by skin prick test,
- Accepted informed consent
Exclusion Criteria:
- Pregnancy or nursing
- Autoimmune or collagen disease (known)
- Cardiovascular disease
- Perennial pulmonary disease
- Hepatic disease
- Renal disease
- Cancer
- Any medication with a possible side-effect of interfering with the immune response
- Previous immuno- or chemotherapy
- Chronic diseases
- Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease)
- Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
- Major metabolic disease
- Known or suspected allergy to the study product
- Alcohol or drug abuse
- Mental incapability of coping with the study
- Withdrawal of informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Active booster
After three basic open label grass allergen ILIT injections the patient is randomized to an active ILIT booster 1 year after the first treatment.
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0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection
Other Names:
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Placebo Comparator: Placebo booster
After three basic open label grass allergen ILIT injections the patient is randomized to a placebo ILIT booster 1 year after the first treatment.
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0.1 mL of ALK Diluent as an intralymphatic injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the serum-level of timothy specific IgG4 after 1 month
Time Frame: Change between baseline and 1 month after treatment.
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Blood samples with measurement of allergen specific blocking IgG4 antibodies
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Change between baseline and 1 month after treatment.
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Change in the serum-level of timothy specific IgG4 after 9 months
Time Frame: Change between baseline and 9 months after treatment.
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Blood samples with measurement of allergen specific blocking IgG4 antibodies
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Change between baseline and 9 months after treatment.
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Change in the serum-level of timothy specific IgG4 2 months after booster
Time Frame: Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).
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Blood samples with measurement of allergen specific blocking IgG4 antibodies
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Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).
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Change in the serum-level of timothy specific IgG4 10 months after booster
Time Frame: Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).
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Blood samples with measurement of allergen specific blocking IgG4 antibodies
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Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lars Olaf Cardell, Professor, Karolinska Institutet
Publications and helpful links
General Publications
- Hylander T, Larsson O, Petersson-Westin U, Eriksson M, Kumlien Georen S, Winqvist O, Cardell LO. Intralymphatic immunotherapy of pollen-induced rhinoconjunctivitis: a double-blind placebo-controlled trial. Respir Res. 2016 Jan 27;17:10. doi: 10.1186/s12931-016-0324-9.
- Konradsen JR, Grundstrom J, Hellkvist L, Tran TAT, Andersson N, Gafvelin G, Kiewiet MBG, Hamsten C, Tang J, Parkin RV, Shamji MH, Hedlin G, Cardell LO, van Hage M. Intralymphatic immunotherapy in pollen-allergic young adults with rhinoconjunctivitis and mild asthma: A randomized trial. J Allergy Clin Immunol. 2020 Mar;145(3):1005-1007.e7. doi: 10.1016/j.jaci.2019.11.017. Epub 2019 Nov 24. No abstract available.
- Weinfeld D, Westin U, Hellkvist L, Mellqvist UH, Jacobsson I, Cardell LO. A preseason booster prolongs the increase of allergen specific IgG4 levels, after basic allergen intralymphatic immunotherapy, against grass pollen seasonal allergy. Allergy Asthma Clin Immunol. 2020 Apr 28;16:31. doi: 10.1186/s13223-020-00427-z. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILIT Borås EPN 2014/251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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