Intralymphatic Immunotherapy in Increasing Doses, Substudy
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy
in increasing doses. Patients with allergy to grass or birch will be treated with three
intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or
placebo.
***IMPORTANT INFORMATION!*** The up-dosing protocol is changed due to adverse events at 5000
SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One
patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic
injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New
regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Karolinska Institutet
Collaborators:
Karolinska University Hospital Skane University Hospital