Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy

38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.

Inclusion criteria

• Age 18-55
• Accepted and signed informed consent.
• Recently (within 20 months) ended a full 3 year program with subcutaneous immunotherapy (SCIT) with amelioration of symptoms but not full symptom relief.

Exclusion criteria

• Previously subcutaneous immunotherapy (SCIT) with total symptom relief.
• Previously SCIT but no symptom improvement at all.
• Sensitizations to house dust mite or furry animals, with symptoms.
• Severe atopic dermatitis.
• Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
• Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2.
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).
• Known autoimmune or collagen disease
• Cardiovascular disease
• Perennial pulmonary disease including asthma
• Hepatic disease
• Known renal insufficiency
• Cancer
• Hematologic disease
• Chronic infectious disease
• Any medication with a possible side-effect of interfering with the immune response
• Previous immuno- or chemotherapy, apart from SCIT
• 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
• Obesity with BMI > 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.
• Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1.
• Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1.
• Mental incapability of coping with the study
• Withdrawal of informed consent