Skip to main content
OpenTrials
Completed

NCT Number: NCT04210193

Is Intralymphatic Allergen Immunotherapy Effective and Safe?

15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Rhinitis Due to Grass Pollen

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Allergy Unit, Södra Älvsborgs Hospital

Borås, 501 82, Sweden

About this study

The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT.

The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires.

The first part of the study is completed and published (PMID: 23374268)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-50,
  • 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 Alutard 5-grasses

Drug

0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection

Other names: Grass allergen with aluminum adjuvant

ALK Diluent

Drug

0.1 mL of ALK Diluent as an intralymphatic injection

Other names: Human albumin

Primary outcomes

  1. Change in the serum-level of timothy specific IgG4 after 1 month

    Time frame: Change between baseline and 1 month after treatment.

    Blood samples with measurement of allergen specific blocking IgG4 antibodies

  2. Change in the serum-level of timothy specific IgG4 after 9 months

    Time frame: Change between baseline and 9 months after treatment.

    Blood samples with measurement of allergen specific blocking IgG4 antibodies

  3. Change in the serum-level of timothy specific IgG4 2 months after booster

    Time frame: Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).

    Blood samples with measurement of allergen specific blocking IgG4 antibodies

  4. Change in the serum-level of timothy specific IgG4 10 months after booster

    Time frame: Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).

    Blood samples with measurement of allergen specific blocking IgG4 antibodies

Sponsors and collaborators

Lead sponsor

Lars Olaf Cardell

Other

Registry information

Official study title

Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 24, 2019
Registry last updated
Dec 24, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.