Is Intralymphatic Allergen Immunotherapy Effective and Safe?

NCT ID: NCT04210193

Last Updated: 2019-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-25
• Study Completion Date: 2019-12-01

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)

Conditions

Allergic Rhinitis Due to Grass Pollen

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

ALK Alutard 5-grasses

Intervention Type: DRUG

0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection

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.

Group Type: PLACEBO_COMPARATOR

ALK Diluent

Intervention Type: DRUG

0.1 mL of ALK Diluent as an intralymphatic injection

Interventions

ALK Alutard 5-grasses

0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection

Intervention Type: DRUG

ALK Diluent

0.1 mL of ALK Diluent as an intralymphatic injection

Intervention Type: DRUG

Other Intervention Names

Grass allergen with aluminum adjuvant; Human albumin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lars Olaf Cardell

OTHER

Sponsor Role: lead

Responsible Party

Lars Olaf Cardell

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lars Olaf Cardell, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Allergy Unit, Södra Älvsborgs Hospital

Borås, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 26817454 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31775016 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32368217 (View on PubMed)

Other Identifiers

ILIT Borås EPN 2014/251

Identifier Type: -

Identifier Source: org_study_id