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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Lars Olaf Cardell · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	ALK Alutard 5-grasses	0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection
DRUG	ALK Diluent	0.1 mL of ALK Diluent as an intralymphatic injection

Timeline

• Start date: 2014-04-25
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-12-24
• Last updated: 2019-12-24

Locations

1 site across 1 country: Sweden