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

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, p...

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Veröffentlicht in:Journal of allergy and clinical immunology 2002-06, Vol.109 (6), p.943-948
Hauptverfasser: Basomba, Antonio, Tabar, Ana I., de Rojas, Dolores Hernández F., Garcı́a, Blanca E., Alamar, Remedios, Olaguı́bel, José M., Prado, Jaime Moscoso del, Martı́n, Santiago, Rico, Pilar
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container_end_page 948
container_issue 6
container_start_page 943
container_title Journal of allergy and clinical immunology
container_volume 109
creator Basomba, Antonio
Tabar, Ana I.
de Rojas, Dolores Hernández F.
Garcı́a, Blanca E.
Alamar, Remedios
Olaguı́bel, José M.
Prado, Jaime Moscoso del
Martı́n, Santiago
Rico, Pilar
description 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.)
doi_str_mv 10.1067/mai.2002.124465
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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 &lt; .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. 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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 &lt; .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.)</description><subject>Adolescent</subject><subject>Adult</subject><subject>Allergies</subject><subject>Antigens, Dermatophagoides</subject><subject>Asthma</subject><subject>Asthma - therapy</subject><subject>Biological and medical sciences</subject><subject>Bronchial Provocation Tests</subject><subject>Desensitization, Immunologic</subject><subject>Diet Records</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Glycoproteins - administration &amp; dosage</subject><subject>Glycoproteins - immunology</subject><subject>Humans</subject><subject>Immunoglobulin E - blood</subject><subject>Immunoglobulin G - blood</subject><subject>Immunopathology</subject><subject>Immunotherapy (general aspects)</subject><subject>Injections</subject><subject>Liposomes</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Skin Tests</subject><issn>0091-6749</issn><issn>1097-6825</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0U2LFDEQBuAgijuunr1JQPRkz-arO93ehvUTFrzoOaST6p0s6aRN0qvrH_JvmmEGFgTxkhB4UlTVi9BzSraUdPJi1m7LCGFbyoTo2gdoQ8kgm65n7UO0IWSgTSfFcIae5HxD6pv3w2N0RhnpeMvYBv3eeQ_pGgK-1ca4oIuLAf9wZY819m6JOc7QQDB6yavXBSyGnyVpU3Cc8DtIsy5x2evr6CxkvBRIMdzl7MKa3-IdTjrYOLtfYN9gG9fRQzN6F-pr8drAGBsTQ0mxdmFxSU577ALWuexrYWfwUk8IJT9FjybtMzw73efo24f3Xy8_NVdfPn6-3F01RkheGjNowcVowPSEdnqYDG8n1gLria3jc9oySycqzCT0KAkbu9qE5CNv60pgkPwcvT7WXVL8vkIuanbZgPc6QFyzkrSnkrTsv5D2UvRckgpf_gVv4ppCHULRloheHIKs6uKoTIo5J5jUktys052iRB2EqlGrQ9TqGHX98eJUdx1nsPf-lG0Fr05AZ6P9VKMwLt87LgWruLrh6KDu9dZBUtnUnRuwLoEpykb3zyb-AEg5x8s</recordid><startdate>20020601</startdate><enddate>20020601</enddate><creator>Basomba, Antonio</creator><creator>Tabar, Ana I.</creator><creator>de Rojas, Dolores Hernández F.</creator><creator>Garcı́a, Blanca E.</creator><creator>Alamar, Remedios</creator><creator>Olaguı́bel, José M.</creator><creator>Prado, Jaime Moscoso del</creator><creator>Martı́n, Santiago</creator><creator>Rico, Pilar</creator><general>Mosby, Inc</general><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7SS</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20020601</creationdate><title>Allergen vaccination with a liposome-encapsulated extract of Dermatophagoides pteronyssinus: A randomized, double-blind, placebo-controlled trial in asthmatic patients</title><author>Basomba, Antonio ; Tabar, Ana I. ; de Rojas, Dolores Hernández F. ; Garcı́a, Blanca E. ; Alamar, Remedios ; Olaguı́bel, José M. ; Prado, Jaime Moscoso del ; Martı́n, Santiago ; Rico, Pilar</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c473t-c9a434bcec8016a9fc35f25e280d0003152d1f14cf4ab702b6ace73b35120e973</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Allergies</topic><topic>Antigens, Dermatophagoides</topic><topic>Asthma</topic><topic>Asthma - therapy</topic><topic>Biological and medical sciences</topic><topic>Bronchial Provocation Tests</topic><topic>Desensitization, Immunologic</topic><topic>Diet Records</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Glycoproteins - administration &amp; dosage</topic><topic>Glycoproteins - immunology</topic><topic>Humans</topic><topic>Immunoglobulin E - blood</topic><topic>Immunoglobulin G - blood</topic><topic>Immunopathology</topic><topic>Immunotherapy (general aspects)</topic><topic>Injections</topic><topic>Liposomes</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Skin Tests</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Basomba, Antonio</creatorcontrib><creatorcontrib>Tabar, Ana I.</creatorcontrib><creatorcontrib>de Rojas, Dolores Hernández F.</creatorcontrib><creatorcontrib>Garcı́a, Blanca E.</creatorcontrib><creatorcontrib>Alamar, Remedios</creatorcontrib><creatorcontrib>Olaguı́bel, José M.</creatorcontrib><creatorcontrib>Prado, Jaime Moscoso del</creatorcontrib><creatorcontrib>Martı́n, Santiago</creatorcontrib><creatorcontrib>Rico, Pilar</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of allergy and clinical immunology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Basomba, Antonio</au><au>Tabar, Ana I.</au><au>de Rojas, Dolores Hernández F.</au><au>Garcı́a, Blanca E.</au><au>Alamar, Remedios</au><au>Olaguı́bel, José M.</au><au>Prado, Jaime Moscoso del</au><au>Martı́n, Santiago</au><au>Rico, Pilar</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Allergen vaccination with a liposome-encapsulated extract of Dermatophagoides pteronyssinus: A randomized, double-blind, placebo-controlled trial in asthmatic patients</atitle><jtitle>Journal of allergy and clinical immunology</jtitle><addtitle>J Allergy Clin Immunol</addtitle><date>2002-06-01</date><risdate>2002</risdate><volume>109</volume><issue>6</issue><spage>943</spage><epage>948</epage><pages>943-948</pages><issn>0091-6749</issn><eissn>1097-6825</eissn><coden>JACIBY</coden><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 &lt; .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.)</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>12063522</pmid><doi>10.1067/mai.2002.124465</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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source MEDLINE; Elsevier ScienceDirect Journals; EZB-FREE-00999 freely available EZB journals
subjects Adolescent
Adult
Allergies
Antigens, Dermatophagoides
Asthma
Asthma - therapy
Biological and medical sciences
Bronchial Provocation Tests
Desensitization, Immunologic
Diet Records
Double-Blind Method
Female
Glycoproteins - administration & dosage
Glycoproteins - immunology
Humans
Immunoglobulin E - blood
Immunoglobulin G - blood
Immunopathology
Immunotherapy (general aspects)
Injections
Liposomes
Male
Medical sciences
Middle Aged
Skin Tests
title Allergen vaccination with a liposome-encapsulated extract of Dermatophagoides pteronyssinus: A randomized, double-blind, placebo-controlled trial in asthmatic patients
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