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NCT Number: NCT02975479

Intralymphatic Immunotherapy in Increasing Doses, Substudy

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.

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Key information

Conditions

Rhinitis, Allergic, Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund, Lund, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALK Diluent

Drug

Other names: 0,3% human albumin. ATC-code V07AB

ALK Alutard SQ 5-grasses or ALK Alutard Birch

Drug

Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.

Other names: Allergen, grass pollen. ATC-code V01AA02 or V01AA05

Primary outcomes

  1. Mean combined daily symptoms-and-medications-score

    Time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).

    Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).

Secondary outcomes

  1. Mean total daily symptoms score

    Time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).

    Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale)

  2. Mean total daily medications score

    Time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).

    Daily scoring of medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).

  3. Change in subjective allergic symptoms following nasal allergen provocation

    Time frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.

    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.

  4. Effects on quality of life

    Time frame: During peak pollen season which will be up to 6 months after completed treatment.

    Juniper Rhinitis quality of life questionnaire (RQLQ) questionnaires

  5. Short term change of skin reactivity

    Time frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.

    Skin prick test

  6. S-IgE Grass or Birch

    Time frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment

  7. S-IgG4 Grass or Birch

    Time frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment

  8. Registration of adverse event

    Time frame: From the first injection to 30 days after the last injections has been given

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital
  • Skane University Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2016
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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