Recombinant grass pollen vaccine(Biomay)(Recombinant grass pollen vaccine(Biomay)) - 在研适应症：过敏性鼻炎_专利_临床

概要

基本信息

药物类型

治疗性疫苗、重组亚单位疫苗

别名

Recombinant grass pollen vaccine

+ [3]

靶点-

作用机制

免疫调节剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 221910

Sequence Code 221919

Sequence Code 221916

Sequence Code 221913

关联

6

项与 Recombinant grass pollen vaccine(Biomay) 相关的临床试验

EUCTR2015-004551-43-AT / Not yet recruiting临床2期

Study to evaluate the effect of different pre-seasonal BM32 dosing schedules on the induction of a protective allergen-specific IgG Immune response

开始日期2016-01-29

申办/合作机构

Biomay AG

NCT02643641 / Completed临床2期

Study to Evaluate the Effect of Different Pre-seasonal BM32 Dosing Schedules on the Rapid Induction of a Protective IgG Immune Response

BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This prospective, double-blind. placebo controlled, mono-centric trial investigates the levels of allergen specific IgG antibodies following 3, 4 or 5 subcutaneous injections before the grass pollen season.

开始日期2016-01-01

申办/合作机构

Biomay AG

EUCTR2012-004194-12-AT / Not yet recruitingN/AIIT

The effect of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy, on immunoglobulin levels in nasal secretions of patients suffering from seasonal allergic rhinitis

开始日期2012-10-23

申办/合作机构-

100 项与 Recombinant grass pollen vaccine(Biomay) 相关的临床结果

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100 项与 Recombinant grass pollen vaccine(Biomay) 相关的转化医学

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100 项与 Recombinant grass pollen vaccine(Biomay) 相关的专利（医药）

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20

项与 Recombinant grass pollen vaccine(Biomay) 相关的文献（医药）

2020-10-01·EBioMedicine1区 · 医学

“Dual use”: The anti-allergy vaccine BM32 and its HBV carrier protein

1区 · 医学

LetterOA

作者: Gerlich, Wolfram H

2020-09-01·eBioMedicine

Quantification, epitope mapping and genotype cross-reactivity of hepatitis B preS-specific antibodies in subjects vaccinated with different dosage regimens of BM32

Article

作者: Lemell, Patrick ; Henning, Rainer ; Tulaeva, Inna ; Zieglmayer, René ; Weber, Milena ; Focke-Tejkl, Margarete ; Valenta, Rudolf ; Karaulov, Alexander ; Zieglmayer, Petra ; Cornelius, Carolin ; Schmutz, René

BACKGROUNDChronic hepatitis B virus (HBV) infections are a global health problem. There is a need for therapeutic strategies blocking continuous infection of liver cells. The grass pollen allergy vaccine BM32 containing the preS domain of the large HBV surface protein (LHBs) as immunogenic carrier induced IgG antibodies in human subjects inhibiting HBV infection in vitro. Aim of this study was the quantification, epitope mapping and investigation of HBV genotype cross-reactivity of preS-specific antibodies in subjects treated with different dosage regimens of BM32 METHODS: Hundred twenty eight grass pollen allergic patients received in a double-blind, placebo-controlled trial five monthly injections of placebo (aluminum hydroxide, n= 34) or different courses of BM32 (2 placebo + 3 BM32, n= 33; 1 placebo + 4 BM32, n= 30; 5 BM32, n= 31). Recombinant Escherichia coli-expressed preS was purified. Overlapping peptides spanning preS and the receptor-binding sites from consensus sequences of genotypes A-H were synthesized and purified. Isotype (IgM, IgG, IgA, IgE) and IgG subclass (IgG₁-IgG₄) responses to preS and peptides were determined by ELISA at baseline, one and four months after the last injection. IgG₁ and IgG₄ subclass concentrations specific for preS and the receptor-binding site were measured by quantitative ELISA.FINDINGSFive monthly injections induced the highest levels of preS-specific IgG consisting mainly of IgG₁ and IgG₄, with a sum of median preS-specific IgG₁ and IgG₄ concentrations of >135 μg/ml reaching up to 1.8 mg/ml. More than 20% of preS-specific IgG was directed against the receptor-binding site. BM32-induced IgG cross-reacted with the receptor-binding domains from all eight HBV genotypes A-H.INTERPRETATIONBM32 induces high levels of IgG₁ and IgG₄ antibodies against the receptor binding sites of all eight HBV genotypes and hence might be suitable for therapeutic HBV vaccination.FUNDINGThis study was supported by the PhD program IAI (KPW01212FW), by Viravaxx AG and by the Danube-ARC funded by the Government of Lower Austria. Rudolf Valenta is a recipient of a Megagrant of the Government of the Russian Federation, grant No 14.W03.31.0024.

2020-02-01·Allergy

Allergen immunotherapy with the hypoallergenic B‐cell epitope‐based vaccine BM32 modifies IL‐10‐ and IL‐5‐secreting T cells

Letter

作者: Henning, Rainer ; Campana, Raffaela ; Pfützner, Wolfgang ; Rauber, Michèle Myriam ; Schulze‐Dasbeck, Manuel ; Weber, Milena ; Valenta, Rudolf ; Focke‐Tejkl, Margarete ; Möbs, Christian ; Greene, Brandon

100 项与 Recombinant grass pollen vaccine(Biomay) 相关的药物交易

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