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Specific subcutaneous immunotherapy with recombinant grass pollen allergens: first randomized dose-ranging safety study.
Clin Exp Allergy. 2012 Jun; 42(6):936-45.CE

Abstract

BACKGROUND

Allergen-specific immunotherapy (SIT) with native allergen extracts and allergoids has been performed successfully for decades. Preliminary studies revealed the use of recombinant allergen-preparations as a promising option for SIT.

OBJECTIVE

The present study was designed to investigate the dose-ranging safety in SCIT with a mixture of five recombinant grass pollen allergens containing equimolar amounts of rPhl p 1, rPhl p2, rPhl p 5a, rPhl p 5b and rPhl p 6, adsorbed to aluminium hydroxide.

METHODS

A randomized, double blind, placebo-controlled, dose-ranging safety study (EudraCT number 2007-002808-18) was performed in 50 patients with allergic rhinoconjunctivitis, with or without asthma. Patients were randomized to groups of 10 to receive maximum doses of 20, 40, 80 or 120 μg of total grass pollen recombinant protein or placebo. The primary end-point of this trial was the number of patients with at least one systemic reaction with possible, probable or definite relationship to the study medication determined at the end of the up-dosing phase. Secondary end-points included titrated intracutaneous test with natural six-grass pollen extract, allergen-specific conjunctival provocation test as well as IgG and IgE-levels throughout the study.

RESULTS

Eight of the 50 patients revealed systemic reactions grade 1 or 2 corresponding to the primary end-point definition. No systemic reactions grade 3 or 4 occurred in any dosage group. The systemic reactions were well distributed among the active groups. Results of secondary end-points imply that the study medication is effective and provokes immunological effects.

CONCLUSIONS AND CLINICAL RELEVANCE

The first DBPC SCIT-DRF with a mixture of recombinant Phleum allergens (Phl p 1, 2, 5a, 5b, 6) in patients with rhinoconjunctivitis plus/minus asthma showed no major side effects in very high doses up to 120 μg.

Authors+Show Affiliations

Center for Rhinology and Allergology, Wiesbaden, Germany. ludger.klimek@allergiezentrum.orgNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22909165

Citation

Klimek, L, et al. "Specific Subcutaneous Immunotherapy With Recombinant Grass Pollen Allergens: First Randomized Dose-ranging Safety Study." Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology, vol. 42, no. 6, 2012, pp. 936-45.
Klimek L, Schendzielorz P, Pinol R, et al. Specific subcutaneous immunotherapy with recombinant grass pollen allergens: first randomized dose-ranging safety study. Clin Exp Allergy. 2012;42(6):936-45.
Klimek, L., Schendzielorz, P., Pinol, R., & Pfaar, O. (2012). Specific subcutaneous immunotherapy with recombinant grass pollen allergens: first randomized dose-ranging safety study. Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology, 42(6), 936-45. https://doi.org/10.1111/j.1365-2222.2012.03971.x
Klimek L, et al. Specific Subcutaneous Immunotherapy With Recombinant Grass Pollen Allergens: First Randomized Dose-ranging Safety Study. Clin Exp Allergy. 2012;42(6):936-45. PubMed PMID: 22909165.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Specific subcutaneous immunotherapy with recombinant grass pollen allergens: first randomized dose-ranging safety study. AU - Klimek,L, AU - Schendzielorz,P, AU - Pinol,R, AU - Pfaar,O, PY - 2012/8/23/entrez PY - 2012/8/23/pubmed PY - 2013/1/9/medline SP - 936 EP - 45 JF - Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology JO - Clin Exp Allergy VL - 42 IS - 6 N2 - BACKGROUND: Allergen-specific immunotherapy (SIT) with native allergen extracts and allergoids has been performed successfully for decades. Preliminary studies revealed the use of recombinant allergen-preparations as a promising option for SIT. OBJECTIVE: The present study was designed to investigate the dose-ranging safety in SCIT with a mixture of five recombinant grass pollen allergens containing equimolar amounts of rPhl p 1, rPhl p2, rPhl p 5a, rPhl p 5b and rPhl p 6, adsorbed to aluminium hydroxide. METHODS: A randomized, double blind, placebo-controlled, dose-ranging safety study (EudraCT number 2007-002808-18) was performed in 50 patients with allergic rhinoconjunctivitis, with or without asthma. Patients were randomized to groups of 10 to receive maximum doses of 20, 40, 80 or 120 μg of total grass pollen recombinant protein or placebo. The primary end-point of this trial was the number of patients with at least one systemic reaction with possible, probable or definite relationship to the study medication determined at the end of the up-dosing phase. Secondary end-points included titrated intracutaneous test with natural six-grass pollen extract, allergen-specific conjunctival provocation test as well as IgG and IgE-levels throughout the study. RESULTS: Eight of the 50 patients revealed systemic reactions grade 1 or 2 corresponding to the primary end-point definition. No systemic reactions grade 3 or 4 occurred in any dosage group. The systemic reactions were well distributed among the active groups. Results of secondary end-points imply that the study medication is effective and provokes immunological effects. CONCLUSIONS AND CLINICAL RELEVANCE: The first DBPC SCIT-DRF with a mixture of recombinant Phleum allergens (Phl p 1, 2, 5a, 5b, 6) in patients with rhinoconjunctivitis plus/minus asthma showed no major side effects in very high doses up to 120 μg. SN - 1365-2222 UR - https://www.unboundmedicine.com/medline/citation/22909165/Specific_subcutaneous_immunotherapy_with_recombinant_grass_pollen_allergens:_first_randomized_dose_ranging_safety_study_ L2 - https://doi.org/10.1111/j.1365-2222.2012.03971.x DB - PRIME DP - Unbound Medicine ER -