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Is Intralymphatic Allergen Immunotherapy Effective and Safe?

Primary Purpose

Allergic Rhinitis Due to Grass Pollen

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
ALK Alutard 5-grasses
ALK Diluent
Sponsored by
Lars Olaf Cardell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis Due to Grass Pollen

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allergy Unit, Södra Älvsborgs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active booster

Placebo booster

Arm Description

After three basic open label grass allergen ILIT injections the patient is randomized to an active ILIT booster 1 year after the first treatment.

After three basic open label grass allergen ILIT injections the patient is randomized to a placebo ILIT booster 1 year after the first treatment.

Outcomes

Primary Outcome Measures

Change in the serum-level of timothy specific IgG4 after 1 month
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Change in the serum-level of timothy specific IgG4 after 9 months
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Change in the serum-level of timothy specific IgG4 2 months after booster
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Change in the serum-level of timothy specific IgG4 10 months after booster
Blood samples with measurement of allergen specific blocking IgG4 antibodies

Secondary Outcome Measures

Full Information

First Posted
December 17, 2019
Last Updated
December 20, 2019
Sponsor
Lars Olaf Cardell
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1. Study Identification

Unique Protocol Identification Number
NCT04210193
Brief Title
Is Intralymphatic Allergen Immunotherapy Effective and Safe?
Official Title
Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2014 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Olaf Cardell

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis Due to Grass Pollen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active booster
Arm Type
Active Comparator
Arm Description
After three basic open label grass allergen ILIT injections the patient is randomized to an active ILIT booster 1 year after the first treatment.
Arm Title
Placebo booster
Arm Type
Placebo Comparator
Arm Description
After three basic open label grass allergen ILIT injections the patient is randomized to a placebo ILIT booster 1 year after the first treatment.
Intervention Type
Drug
Intervention Name(s)
ALK Alutard 5-grasses
Other Intervention Name(s)
Grass allergen with aluminum adjuvant
Intervention Description
0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection
Intervention Type
Drug
Intervention Name(s)
ALK Diluent
Other Intervention Name(s)
Human albumin
Intervention Description
0.1 mL of ALK Diluent as an intralymphatic injection
Primary Outcome Measure Information:
Title
Change in the serum-level of timothy specific IgG4 after 1 month
Description
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Time Frame
Change between baseline and 1 month after treatment.
Title
Change in the serum-level of timothy specific IgG4 after 9 months
Description
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Time Frame
Change between baseline and 9 months after treatment.
Title
Change in the serum-level of timothy specific IgG4 2 months after booster
Description
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Time Frame
Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).
Title
Change in the serum-level of timothy specific IgG4 10 months after booster
Description
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Time Frame
Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Olaf Cardell, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Unit, Södra Älvsborgs Hospital
City
Borås
ZIP/Postal Code
501 82
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26817454
Citation
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.
Results Reference
background
PubMed Identifier
31775016
Citation
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.
Results Reference
background
PubMed Identifier
32368217
Citation
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.
Results Reference
derived

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Is Intralymphatic Allergen Immunotherapy Effective and Safe?

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