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Vol. 137, No. 3, 2005
Issue release date: July 2005
Section title: Original Paper
Int Arch Allergy Immunol 2005;137:211–218
(DOI:10.1159/000086333)

Comparative Study of Tolerance between Unmodified and High Doses of Chemically Modified Allergen Vaccines of Dermatophagoides pteronyssinus

Casanovas M.a · Fernández-Caldas E.a · Alamar R.b · Basomba A.b
aLaboratorios LETI, S.L., Tres Cantos, Madrid, and bServicio de Alergia, Hospital la Fe, Valencia, Spain

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 10/18/2004
Accepted: 2/21/2005
Published online: 7/8/2005
Issue release date: July 2005

Number of Print Pages: 8
Number of Figures: 2
Number of Tables: 5

ISSN: 1018-2438 (Print)
eISSN: 1423-0097 (Online)

For additional information: http://www.karger.com/IAA

Abstract

Background: The physiochemical modification of allergens to reduce allergenicity, while retaining immunogenicity, provides a chance for the administration of higher doses of immunotherapy, with a decreased risk of systemic reactions. Objective: To evaluate the safety of doses of depigmented glutaraldehyde-polymerized vaccine of Dermatophagoides pteronyssinus increasing those used in normal clinical conditions in comparison with regular doses of a non-modified vaccine. Materials and Methods: The study was double-blind, parallel and included two patient groups. Twenty-three patients were treated weekly during 9 visits for the build-up phase, followed by 2-weekly maintenance doses (a total of 11 injections per patient). Eleven patients (mean age 22 years) received immunotherapy with the standardized modified vaccine. The maximum dose used was the result of depigmenting and polymerizing 100 times the maximum dose used with the native extract. The maximum concentration used was 990 µg/ml of freeze-dried material. Twelve patients (mean age 24 years) received a standardized, unmodified allergenic extract. The maximum concentration used was 70 µg of freeze-dried material/ml, with a potency of 10 HEPL/ml. The tolerance was evaluated recording all the side reactions related to immunotherapy and graded following the recommendations of the European Academy of Allergology and Clinical Immunology. Results: In both groups, all immediate local reactions were clinically not relevant. Patients treated with the native extract experienced 42 local immediate and 24 delayed reactions (1 of them had a diameter >10 cm), whereas patients treated with the modified extract experienced 30 local immediate and 21 delayed reactions (2 of them had a diameter >10 cm). Four systemic reactions in 2 patients, 1 immediate of grade 1 and 3 delayed of grade 2 were reported in the group treated with native extract and 1 delayed of grade 2 in the group treated with the modified preparation. Conclusions: The modified extract of D. pteronyssinus, used at concentrations which are 10 times higher than those regularly administered in clinical practice, demonstrated to be safe to treat D. pteronyssinus-sensitive patients. The major ity of the local reactions (immediate and delayed) were clinically not relevant (diameter <5 cm). No systemic reactions of grade 3 or 4 were noted.

© 2005 S. Karger AG, Basel


  

Author Contacts

Correspondence to: Dr. M. Casanovas
Laboratorios LETI, S.L.
Calle del Sol, 5
ES–28760 Tres Cantos, Madrid (Spain)
Tel. +34 917711790, Fax +34 918040919, E-Mail mcasanovas@leti.com

  

Article Information

Received: October 18, 2004
Accepted after revision: February 21, 2005
Published online: June 9, 2005
Number of Print Pages : 8
Number of Figures : 2, Number of Tables : 5, Number of References : 39

  

Publication Details

International Archives of Allergy and Immunology

Vol. 137, No. 3, Year 2005 (Cover Date: July 2005)

Journal Editor: Valenta, R. (Vienna)
ISSN: 1018–2438 (print), 1423–0097 (Online)

For additional information: http://www.karger.com/iaa


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 10/18/2004
Accepted: 2/21/2005
Published online: 7/8/2005
Issue release date: July 2005

Number of Print Pages: 8
Number of Figures: 2
Number of Tables: 5

ISSN: 1018-2438 (Print)
eISSN: 1423-0097 (Online)

For additional information: http://www.karger.com/IAA


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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