Intralymphatic Immunotherapy in Increasing Doses, Substudy

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; Skane University Hospital

Criteria

Inclusion Criteria:

• 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