Allergen vaccination with a liposome-encapsulated extract of Dermatophagoides pteronyssinus : A randomized, double-blind, placebo-controlled trial in asthmatic patients

doi:10.1067/mai.2002.124465

Journal of Allergy and Clinical Immunology

Volume 109, Issue 6, June 2002, Pages 943-948

https://doi.org/10.1067/mai.2002.124465 Get rights and content

Abstract

Background: Liposomes are potent immunologic adjuvants and have been proposed as allergen carriers in allergy vaccination. Objective: We sought to investigate the efficacy and safety of vaccination with Dermatophagoides pteronyssinus encapsulated in liposomes. Methods: We conducted a double-blind, placebo-controlled study. Fifty-five asthmatic patients sensitized to mites were randomly assigned vaccination with D pteronyssinus extract encapsulated in liposomes or empty liposomes for a period of 12 months. The principal parameters were symptom and medication-consumption scores. The percentage of healthy days (ie, days without medication and with absent or mild symptoms) was calculated. Immediate and late skin test results, allergen bronchial challenge test results, and allergen-specific serum immunoglobulin levels were evaluated before and after treatment. Results: All clinical scores were markedly lower in the active group than in the placebo group after vaccination. Nearly half (45.8%) of the patients actively treated reduced their symptom and medication scores by at least 60% versus only 12% of patients receiving placebo treatment (P = .0388). The percentage of healthy days in the active group rose from 10.5% before treatment to 64.5% afterward (P = .0008). Reduction in organ sensitivity was demonstrated by skin prick test responses (P < .01), late-phase response after intradermal testing (P = .009), and bronchial challenge test results (P = .026) in the active group. Serum levels of specific IgG increased throughout the treatment, whereas specific IgE levels showed only an initial transient increase. No change in these parameters was observed in the placebo group. Vaccination was well tolerated, and no subcutaneous nodules appeared. Conclusion: Vaccination with D pteronyssinus encapsulated in liposomes is an effective and safe treatment for allergy-induced asthma. (J Allergy Clin Immunol 2002;109:943-8.)

Section snippets

Study design

The study was designed as a 1-year, double-blind, placebo-controlled trial and was approved by the ethics committees of the participating hospitals. All patients provided written informed consent. During a run-in period, baseline subjective and objective parameters were assessed. All these parameters were re-evaluated after 1 year of treatment. The principal outcome parameters were the symptom score, the consumption of medication, and the combined symptom and medication score. Secondary outcome

Patients

At enrollment, the active and placebo groups were comparable in terms of age, sex, disease severity, and disease duration, as shown in Table I.

. Characteristics of patients at baseline

Empty Cell	Active group (n = 29)	Placebo group (n = 26)
Demographics
Age (y)	21 (14-50)	22 (14-38)
Sex (M/F)	14/15	14/12
Disease duration (y)	9 (1-23)	6 (1-23)
Severity of disease (mild/moderate/severe)
Asthma	20/9/0	17/9/0
Rhinitis*	11/13/1	10/14/0
Lung function (% of normal)
FEV₁	88.0 (69-113)	88.0 (59-109)
FVC	85.0 (71-116)	88.5 (67-113)
*Four

Discussion

We have demonstrated the efficacy and safety of SAV with D pteronyssinus encapsulated in liposomes in monosensitized asthmatic patients. Liposomes are nontoxic and biodegradable and exert an immunomodulatory effect (IgG enhancement and decrease of IgE levels)⁴ that makes them suitable for allergen vaccination. Moreover, several liposome properties (lamellarity, size, lipid composition, and charge) might affect the immunoadjuvanticity and biologic responses to a liposomal allergen preparation.

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^☆: Reprint requests: Pilar Rico, MD, ALK-ABELLÓ, S.A., Miguel Fleta, 19, 28037 Madrid, Spain.

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Asthma, Rhinitis, Other Respiratory DiseasesAllergen vaccination with a liposome-encapsulated extract of Dermatophagoides pteronyssinus : A randomized, double-blind, placebo-controlled trial in asthmatic patients☆

Abstract

Section snippets

Study design

Patients

Discussion

Immunol Today

J Allergy Clin Immunol

J Allergy Clin Immunol

J Immunol Methods

J Allergy Clin Immunol

WHO Position Paper. Allergen immunotherapy: therapeutic vaccines for allergic diseases

Allergy

Is allergen immunotherapy effective in asthma? A meta-analysis of randomised controlled trials

Am J Respir Crit Care Med

Long-term clinical efficacy grass-pollen immunotherapy

N Engl J Med

Liposomes as vehicle for allergen presentation in the immunotherapy of allergic diseases

Allergy

Use of liposomes for standardized therapeutic allergens

Liposomes as carriers for allergy immunotherapy

Clin Exp Allergy

Humoral and cellular immune responses induced by long-term immunisation with liposome-encapsulated antigens

Allergy

Pharmacokinetics of D. pteronyssinus encapsulated in liposomes

Clin Exp Allergy

Delivery systems for immunomodulatory proteins and peptides

Biodrugs

A 1-year, placebo-controlled, double-blind house-dust mite immunotherapy study in asthmatic adults

Allergy

Asthma, Rhinitis, Other Respiratory Diseases
Allergen vaccination with a liposome-encapsulated extract of Dermatophagoides pteronyssinus : A randomized, double-blind, placebo-controlled trial in asthmatic patients☆