Methods:
In an open pilot investigation followed by a double-blind, placebo-controlled study, patients with allergic rhinitis were treated with 3 intralymphatic inguinal injections of Cry j1 or placebo. At visit 2 to 4, the study subjects received three 0.1 ml injections with either placebo or 20 JAU of a standardized Japanese pollen extracts. Using ultrasound guidance and a 25-gauge needle, a superficial inguinal lymph node in right groin was aseptically injected for 30 seconds. Clinical pre and post treatment outcomes and the activation pattern of peripheral antibodies were assessed.
Results: Intralymphatic immunotherapy (ILIT) with Cry j1 did not elicit any severe adverse events. Patients receiving active treatment displayed an initial increase in allergen-specific IgE and IgG level. A clinical improvement was seen in active treatment group, but not in the placebo group.
Conclusions: ILIT with Japanese pollen extracts indicate the clinical improvement without causing severe adverse events.