Pollenvaccination in humans, via a lymph node, with doses up to 10 000SQ-U. .

Phase 1

• Conditions: Patients with severe to moderate Allegic rhinitis.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-001259-63-SE
• Lead Sponsor: Department of Clinical Science, Intervention and Technology, Karolinska Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-08
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Main study
Age 18-50
Accepted and signed informed consent.
Recently (within 12 months) ended a full 3 year SCIT-program with amelioration of symptoms but not full symptom relief.
Substudy :
Age 18-50
Accepted and signed informed consent.
Moderate to severe seasonal allergic symptoms for grass or birch. Severity levels are assessed by weighing together patient’s medical history, allergen specific S-IgE and skin-prick test reaction. The patient’s subjective description of symptom load during pollen season is most important.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Previously SCIT with total symptom relief.
Previously SCIT but no symptom improvement at all.
Sensitizations to house dust mite or fur 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
Hyper-IgE-syndrome
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 ß-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified