A Single-center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Relative Efficacy and Safety of Immunotherapy With SUBLIVAC FIX Phleum Pratense in Grass Pollen-Allergic Subjects With IgE-Mediated Seasonal ARC

The purpose of this study is to assess safety, tolerability and demonstrate a dose response signal using Total Symptom Score (TSS), based on challenges with grass pollen in an Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo.
The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.

Start Date01 Sep 2015

Sponsor / Collaborator

HAL Allergy Holding BV

EUCTR2010-021235-13-DE / Not yet recruitingNot Applicable

A randomized, double-blind, placebo-controlled study to determine safety, tolerability and the optimal effective dose of SUBLIVAC FIX Phleum pratense in patients with allergic rhinitis/rhinoconjunctivitis caused by grass pollen - SUBLIVAC FIX Phleum pratense DT/DRF

Start Date04 Sep 2012

Sponsor / Collaborator-

NCT01682070 / CompletedPhase 2

A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Phleum Pratense in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Grass Pollen

The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum pratense based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Phleum pratense compared to placebo.

Start Date01 Sep 2012

Sponsor / Collaborator

HAL Allergy Holding BV

100 Clinical Results associated with Phleum pratense pollen allergy immunotherapy(HAL Allergy Holding BV)

100 Translational Medicine associated with Phleum pratense pollen allergy immunotherapy(HAL Allergy Holding BV)

100 Patents (Medical) associated with Phleum pratense pollen allergy immunotherapy(HAL Allergy Holding BV)

Literatures (Medical) associated with Phleum pratense pollen allergy immunotherapy(HAL Allergy Holding BV)

01 Jun 2010·European annals of allergy and clinical immunology

The biological potency of different extracts for sublingual immunotherapy assessed by skin prick tests.

Article

Author: Rossi, R ; Monasterolo, G ; Passalacqua, G

The standardization of allergen extracts is of primary relevance to the clinical efficacy. Biological standardization procedures are widely used in the commercial production of vaccines. We tested, in grass-allergic patients, the potency of three different grass extracts for sublingual immunotherapy by means of skin prick tests. Specific IgE against Phl p 1, 2, 4, 5, 7, 11 and 12 were also assayed. Allerslit and Sublivac were directly applied as skin test. Grazax, was prepared by dissolving two tablets in 2 mL saline. Thirty-three subjects (mean age 38.8) were studied. The skin response was significantly different among extracts, decreasing from Allerslit to Grazax (t test < 0.01), but all the extract produced a skin response greater than histamine. All the subjects had specific IgE to Phl p 1 and Phl p 4 but 24% did not have specific IgE to Phl p 5. In those subjects the skin response to the three extracts did not differ from that of Phl p 5-positive subjects. Our findings confirm that there is a variability in the biological potency among different extracts. In addition, the standardization of grass extracts based on Phlp 5 only, may be insufficient in some cases.

Frontiers in Pediatrics

Eosinophilic esophagitis improved by the discontinuation of sublingual immunotherapy for aeroallergens: a case report

Author: Curto, Sara ; Mercalli, Francesca ; Coppola, Marta ; Saettone, Silvia ; Lovaste, Sara ; Cerutti, Marta ; Monzani, Alice ; Rabbone, Ivana

IntroductionEosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammation of the esophagus, characterized by symptoms related to esophageal dysfunction, resulting from severe eosinophilic infiltration of the esophageal mucosa. It is common in atopic subjects and food antigens have been identified as the most common triggers. However, a seasonal variation in EoE prevalence, correlated with air pollen levels, is reported, suggesting that also aeroallergens may play a role. Little is known about the interplay between EoE and concomitant atopy treatment for aeroallergens.Case presentationWe describe the case of an 11-year-old boy who presented dysphagia, vomiting, drooling, and chest pain while eating meat, developed 15 months after receiving sublingual immunotherapy (SLIT) for Alternaria (SUBLIVAC®). He underwent esophagogastroduodenoscopy (EGD) revealing severe eosinophilic predominant inflammation (100 eos/HPF), consistent with the diagnosis of EoE, not improving at the EGDs performed after both omeprazole and topical corticosteroids treatment, despite symptom improvement. Afterward, immunotherapy was switched from sublingual to injective form. At the EGD performed 1 month later, macroscopic examination of the esophageal mucosa was normal and eosinophilic infiltration was significantly decreased (5–10 eos/HPF).ConclusionsSLIT may induce EoE by chronic antigenic exposure of oral mucosa in patients with a robust allergic susceptibility: while attenuating the IgE-mediated immune reactions, the progressive contact with the causative allergen might induce a chronic stimulation of the immune system with the consequent activation of tissue eosinophils. Our data suggest monitoring patients receiving SLIT for EoE symptoms and to discontinue SLIT on their earlier appearance, possibly as a first-line treatment.

100 Deals associated with Phleum pratense pollen allergy immunotherapy(HAL Allergy Holding BV)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Conjunctivitis, Allergic	Phase 3	-	HAL Allergy Holding BV	-
Rhinitis, Allergic, Seasonal	Preclinical	BE	HAL Allergy Holding BV	01 Sep 2006
Rhinitis, Allergic, Seasonal	Discovery	DE	HAL Allergy Holding BV	01 Sep 2006
Rhinitis, Allergic, Seasonal	Discovery	PL	HAL Allergy Holding BV	01 Sep 2006
Rhinitis, Allergic, Seasonal	Discovery	NL	HAL Allergy Holding BV	01 Sep 2006
Allergic rhinoconjunctivitis	Discovery	CA	HAL Allergy BV	-
Allergic rhinoconjunctivitis	Discovery	DE	HAL Allergy BV	-
Rhinitis, Allergic	Discovery	DE	HAL Allergy BV	-
Rhinitis, Allergic	Discovery	PL	HAL Allergy BV	-
Rhinitis, Allergic	Discovery	CA	HAL Allergy BV	-

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