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.
RCT Entities:
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: Andrzej Bozek; Marek Jąkalski; Monika Jonska-Golus; Agata Filipowska-Gronska; Jerzy Jarząb; Giorgio Walter Canonica Journal: Hum Vaccin Immunother Date: 2018-09-14 Impact factor: 3.452
Authors: Sarah K Wise; Sandra Y Lin; Elina Toskala; Richard R Orlandi; Cezmi A Akdis; Jeremiah A Alt; Antoine Azar; Fuad M Baroody; Claus Bachert; G Walter Canonica; Thomas Chacko; Cemal Cingi; Giorgio Ciprandi; Jacquelynne Corey; Linda S Cox; Peter Socrates Creticos; Adnan Custovic; Cecelia Damask; Adam DeConde; John M DelGaudio; Charles S Ebert; Jean Anderson Eloy; Carrie E Flanagan; Wytske J Fokkens; Christine Franzese; Jan Gosepath; Ashleigh Halderman; Robert G Hamilton; Hans Jürgen Hoffman; Jens M Hohlfeld; Steven M Houser; Peter H Hwang; Cristoforo Incorvaia; Deborah Jarvis; Ayesha N Khalid; Maritta Kilpeläinen; Todd T Kingdom; Helene Krouse; Desiree Larenas-Linnemann; Adrienne M Laury; Stella E Lee; Joshua M Levy; Amber U Luong; Bradley F Marple; Edward D McCoul; K Christopher McMains; Erik Melén; James W Mims; Gianna Moscato; Joaquim Mullol; Harold S Nelson; Monica Patadia; Ruby Pawankar; Oliver Pfaar; Michael P Platt; William Reisacher; Carmen Rondón; Luke Rudmik; Matthew Ryan; Joaquin Sastre; Rodney J Schlosser; Russell A Settipane; Hemant P Sharma; Aziz Sheikh; Timothy L Smith; Pongsakorn Tantilipikorn; Jody R Tversky; Maria C Veling; De Yun Wang; Marit Westman; Magnus Wickman; Mark Zacharek Journal: Int Forum Allergy Rhinol Date: 2018-02 Impact factor: 3.858
Authors: Margarete Focke-Tejkl; Milena Weber; Katarzyna Niespodziana; Angela Neubauer; Hans Huber; Rainer Henning; Gottfried Stegfellner; Bernhard Maderegger; Martina Hauer; Frank Stolz; Verena Niederberger; Katharina Marth; Julia Eckl-Dorna; Richard Weiss; Josef Thalhamer; Katharina Blatt; Peter Valent; Rudolf Valenta Journal: J Allergy Clin Immunol Date: 2014-11-13 Impact factor: 10.793