Is Intralymphatic Allergen Immunotherapy Effective and Safe?

NCT04210193 | Completed Phase 2 DMC

• 1 other identifier: ILIT Borås EPN 2014/251
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis Due to Grass Pollen

Outcome Measures

Primary Outcomes (4)

• Change in the serum-level of timothy specific IgG4 after 1 month

  Blood samples with measurement of allergen specific blocking IgG4 antibodies

  Change between baseline and 1 month after treatment.

• Change in the serum-level of timothy specific IgG4 after 9 months

  Blood samples with measurement of allergen specific blocking IgG4 antibodies

  Change between baseline and 9 months after treatment.

• Change in the serum-level of timothy specific IgG4 2 months after booster

  Blood samples with measurement of allergen specific blocking IgG4 antibodies

  Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).

• Change in the serum-level of timothy specific IgG4 10 months after booster

  Blood samples with measurement of allergen specific blocking IgG4 antibodies

  Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).

Study Arms (2)

Active booster

ACTIVE COMPARATOR

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

Drug: ALK Alutard 5-grasses

Placebo booster

PLACEBO COMPARATOR

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

Drug: ALK Diluent

Interventions

ALK Alutard 5-grasses DRUG

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

Also known as: Grass allergen with aluminum adjuvant

Active booster

ALK Diluent DRUG

0.1 mL of ALK Diluent as an intralymphatic injection

Also known as: Human albumin

Placebo booster

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50,
• Seasonal allergic symptoms for birch and/or grass verified by skin prick test,
• Accepted informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Lars Olaf Cardell: lead

Study Sites (1)

Allergy Unit, Södra Älvsborgs Hospital

Borås, 501 82, Sweden

Location

Related Publications (3)

• 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.

  PMID: 26817454 BACKGROUND

• 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.

  PMID: 31775016 BACKGROUND

• 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.

  PMID: 32368217 DERIVED

MeSH Terms

Interventions

Serum Albumin, Human

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Lars Olaf Cardell, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 24, 2019
• Study Start: April 25, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)