Birch pollen allergy vaccine(HAL Allergy Holding BV)(Birch pollen allergy vaccine(HAL Allergy Holding BV)) - 在研适应症：变应性结膜炎，过敏性鼻炎_专利_临床

概要

基本信息

药物类型

变应原提取物

别名

Birch pollen allergy vaccine、SUBLIVAC FIX Birch

靶点-

作用机制

免疫调节剂

治疗领域

免疫系统疾病感染眼部疾病+ [2]

在研适应症

变应性结膜炎过敏性鼻炎

非在研适应症

鼻结膜炎

原研机构

HAL Allergy Holding BV

在研机构

HAL Allergy Holding BV

非在研机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Birch pollen allergy vaccine(HAL Allergy Holding BV) 相关的临床试验

NCT02345278 / Completed临床1/2期

A Randomized, Double-blind, Placebo-controlled Study to Determine Tolerability and Safety of Different Dosages of SUBLIVAC FIX Mite Mixture in Patients With Allergic Rhinitis / Rhinoconjunctivitis Caused by House Dust Mites

Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy and specific immunotherapy (IT). IT represents the only treatment that might alter the natural course of the disease. The amount of administered allergen is crucial for both efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for sublingual IT (SLIT) and is indicated for the treatment of allergic disorders such as allergic rhinitis and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM) allergens.
According to the European Medicines Agency Guideline on the clinical development of products for specific IT for the treatment of allergic diseases, products should be tested at different dosages to provide preliminary data on safety and tolerability with regard to the maximum tolerated dose and suitable dose escalation scheme. This trial is designed to investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.

开始日期2015-05-01

申办/合作机构

HAL Allergy Holding BV

NCT02231307 / Completed临床3期

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Clinical Efficacy and Safety of SUBLIVAC FIX Birch Immunotherapy in Patients Suffering From Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen.

The aim of this phase III study is to asses if SUBLIVAC FIX Birch is safe and effective in reducing birch allergy induced symptoms and birch allergy medication usage.

开始日期2014-09-01

申办/合作机构

HAL Allergy Holding BV

NCT01639768 / Completed临床2期

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

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

开始日期2012-07-01

申办/合作机构

HAL Allergy Holding BV

100 项与 Birch pollen allergy vaccine(HAL Allergy Holding BV) 相关的临床结果

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100 项与 Birch pollen allergy vaccine(HAL Allergy Holding BV) 相关的转化医学

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100 项与 Birch pollen allergy vaccine(HAL Allergy Holding BV) 相关的专利（医药）

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3

项与 Birch pollen allergy vaccine(HAL Allergy Holding BV) 相关的文献（医药）

2013-04-01·The Journal of Immunology2区 · 医学

A Nonallergenic Birch Pollen Allergy Vaccine Consisting of Hepatitis PreS–Fused Bet v 1 Peptides Focuses Blocking IgG toward IgE Epitopes and Shifts Immune Responses to a Tolerogenic and Th1 Phenotype

2区 · 医学

Article

作者: Marth, Katharina ; Valenta, Rudolf ; Shamji, Mohamed H. ; Swoboda, Ines ; Gieras, Anna ; Breyer, Isabella ; Focke-Tejkl, Margarete ; Valent, Peter ; Blatt, Katharina ; Layhadi, Janice ; Durham, Stephen R. ; Zafred, Domen ; Keller, Walter

AbstractAllergen-specific immunotherapy is the only allergen-specific and disease-modifying treatment for allergy. The construction and characterization of a vaccine for birch pollen allergy is reported. Two nonallergenic peptides, PA and PB, derived from the IgE-reactive areas of the major birch pollen allergen Bet v 1 were fused to the hepatitis B surface protein, PreS, in four recombinant fusion proteins containing different numbers and combinations of the peptides. Fusion proteins expressed in Escherichia coli and purified to homogeneity showed a lack of IgE reactivity and allergenic activity when tested with sera and basophils from patients allergic to birch pollen. Compared to Bet v 1 allergen, peptides PA and PB showed reduced T cell activation in PBMCs from allergic patients, whereas PreS fusion proteins induced less IL-5 and more IL-10 and IFN-γ. Immunization of rabbits with the fusion proteins, in particular with a PreS fusion protein 2PAPB-PreS, containing two copies of each peptide, induced high levels of IgG Abs against the major IgE-reactive site on Bet v 1 and related allergens. These IgG Abs inhibited allergic patients’ IgE binding to Bet v 1 better than did IgG induced by immunization with complete Bet v 1. Furthermore, 2PAPB-PreS–induced IgG inhibited Bet v 1–induced basophil activation in allergic patients and CD23-facilitated allergen presentation. Our study exemplifies novel beneficial features for a PreS carrier–based peptide vaccine for birch pollen, which, in addition to the established reduction in allergenic activity, include the enhanced focusing of blocking Ab responses toward IgE epitopes, immunomodulatory activity, and reduction of CD23-facilitated allergen presentation.

2010-12-01·Human Vaccines

Recombinant Bet v 1 vaccine for treatment of allergy to birch pollen

Review

作者: Hans Grönlund ; Guro Gafvelin

Therapeutic vaccination is the only disease modifying allergy treatment. Recombinant allergen vaccines represent defined component vaccines and are advantageous compared to allergen extract vaccines because of their well defined and measurable allergen content. As the major birch pollen allergen Bet v 1 is the dominant disease-eliciting allergen in birch pollen Bet v 1 vaccines based on GMP produced recombinant (r)Bet v 1 have been developed for treatment of birch pollen allergic patients. Three vaccines comprising hypoallergenic rBet v 1 derivatives have in clinical trials been shown to improve allergic symptoms and to favourable modify the immune response to Bet v 1. In a phase II trial, vaccination with rBet v 1 resulted in reduced rhinoconjunctivitis symptoms and rescue medication compared to placebo. Vaccination with rBet v 1 formulated as tablets for sublingual administration revealed clinical relevant efficacy in rhinoconjunctivitis patients. The positive results imply that rBet v 1 vaccines constitute a therapeutic alternative for birch pollen allergic patients.

2008-11-01·Journal of Allergy and Clinical Immunology1区 · 医学

Efficacy of recombinant birch pollen vaccine for the treatment of birch-allergic rhinoconjunctivitis

1区 · 医学

Article

作者: Elide Pastorello ; Gabrielle Pauli ; Ashok Purohit ; Hans-Jorgen Malling ; Sylvie Galvain ; Tina H. Larsen ; Michel Melac ; Nadine Mothes ; Monica Arvidsson ; Armelle Montagut ; Claude André ; Susanne Spitzauer ; Alexander Kavina ; Friedrich Horak ; Sabina Rak ; Rudolph Valenta ; Jan W. Schroeder ; Lars K. Poulsen

BACKGROUNDRecombinant DNA technology has the potential to produce allergen-specific immunotherapy vaccines with defined composition.OBJECTIVETo evaluate the effectiveness of a new recombinant birch pollen allergen vaccine in patients with birch pollen allergy.METHODSA multicenter, randomized, double-blind, placebo-controlled trial was undertaken to compare the following 3 vaccines in 134 adults with birch pollen allergy: recombinant birch pollen allergen vaccine (rBet v 1a), licensed birch pollen extract, natural purified birch pollen allergen (nBet v 1), and placebo. Patients received 12 weekly injections followed by monthly injections of the maintenance dose containing 15 microg Bet v 1 for 2 years.RESULTSSignificant reductions (about 50%) in rhinoconjunctivitis symptoms (rBet v 1, P = .0002; nBet v 1, P = .0006; birch extract, P = .0024), rescue medication (rBet v 1, P = .0011; nBet v 1, P = .0025; birch extract, P = .0063), and skin sensitivities (P < .0001) were observed in the 3 actively treated groups compared with placebo during 2 consecutive pollen seasons. Clinical improvement was accompanied by marked increases in Bet v 1-specific IgG levels, which were higher in the rBet v 1-treated group than in the birch and nBet v 1-treated groups. New IgE specificities were induced in 3 of 29 patients treated with birch pollen extract, but in none of the 32 rBet v 1-treated or 29 nBet v 1-treated patients. No severe systemic adverse events were observed in the rBet v 1-treated group.CONCLUSIONThe rBet v 1-based vaccine was safe and effective in treating birch pollen allergy, and induced a highly specific immune response.

100 项与 Birch pollen allergy vaccine(HAL Allergy Holding BV) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	国家/地区	公司	日期
变应性结膜炎	-	HAL Allergy Holding BV	-
过敏性鼻炎	-	HAL Allergy Holding BV	-

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适应症	最高研发状态	国家/地区	公司	日期
过敏性鼻炎	药物发现	德国	HAL Allergy Holding BV	2014-09-01
过敏性鼻炎	药物发现	斯洛伐克	HAL Allergy Holding BV	2014-09-01
过敏性鼻炎	药物发现	波兰	HAL Allergy Holding BV	2014-09-01
过敏性鼻炎	药物发现	捷克	HAL Allergy Holding BV	2014-09-01
过敏性鼻炎	药物发现	比利时	HAL Allergy Holding BV	2014-09-01
变应性结膜炎	药物发现	捷克	HAL Allergy Holding BV	2012-07-01
变应性结膜炎	药物发现	德国	HAL Allergy Holding BV	2012-07-01
鼻结膜炎	药物发现	波兰	HAL Allergy Holding BV	2012-07-01
鼻结膜炎	药物发现	德国	HAL Allergy Holding BV	2012-07-01
鼻结膜炎	药物发现	捷克	HAL Allergy Holding BV	2012-07-01