Intralymphatic Immunotherapy in Increasing Doses, Substudy

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U - a Human Randomized Clinical Trial. Substudy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975479
• Other study ID #: 2015-001259-63 substudy
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2016
• Est. completion date: June 20, 2022

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• ALK Diluent

• ALK Alutard SQ 5-grasses or ALK Alutard Birch
Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.

Locations

Country	Name	City	State
Sweden	Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund	Lund
Sweden	ENT-department, Karolinska University Hospital Huddinge (ENT-department B51)	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital, Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean combined daily symptoms-and-medications-score	Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).	Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Secondary	Mean total daily symptoms score	Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale)	Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Secondary	Mean total daily medications score	Daily scoring of medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).	Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Secondary	Change in subjective allergic symptoms following nasal allergen provocation	The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation.	Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.
Secondary	Effects on quality of life	Juniper Rhinitis quality of life questionnaire (RQLQ) questionnaires	During peak pollen season which will be up to 6 months after completed treatment.
Secondary	Short term change of skin reactivity	Skin prick test	Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.
Secondary	S-IgE Grass or Birch		Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
Secondary	S-IgG4 Grass or Birch		Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
Secondary	Registration of adverse event		From the first injection to 30 days after the last injections has been given