CyTuVax开始其第2阶段的响应！研究

StephenW

                        CyTuVax starts its Phase 2 BE RESPONDER! study                                                                                                                 Category: Vaccines                                                                Published on Thursday, 09 March 2017 19:18                                Hits: 100                                         

Effective vaccination for hepatitis B non-respondersMAASTRICHT, The Netherlands I March 8, 2016 I CyTuVax, a life science company focusing on the development of novel vaccines, today reported the start of a phase 2 study assessing the efficacy and safety of its lead product HBAI20, a hepatitis B vaccine for non-responders.
Non-responders are persons who failed to build up sufficient immune protection even after receiving 6 vaccinations with a standard vaccine. Results of the phase 1 study showed that the HBAI20 vaccine induced protective immunity against hepatitis B in 90% of the non-responders. The study also showed that the safety and toxicity profile of the HBAI20 vaccine was comparable to that of a standard hepatitis B vaccine. This exciting result will now be built upon in the BE RESPONDER! study with 140 non-responders.
The HBAI20 vaccine is intended to fulfil a high unmet medical need among persons requiring protective titers against hepatitis B. Five percent of the population is unable to generate protective levels of antibody titers. These non-responders are not protected against infection with the hepatitis B virus that can result in a chronic and fatal disease. Most at risk of contracting hepatitis B are healthcare workers due to potential exposure to body fluids containing hepatitis B virus. Patients who can also benefit are transplant recipients, HIV, diabetes, and dialysis patients.
The BE RESPONDER! trial is a double blinded multi-center international clinical trial enrolling non-responders after 3 or more hepatitis B vaccinations. They will receive either the HBAI20 vaccine or a standard hepatitis B vaccine as control. Dr. Astrid Oude Lashof, dr. Geert Robaeys and prof. Pierre van Damme will conduct the study and are responsible for the clinical trial centers of Maastricht University Medical Center, the Ziekenhuis Oost Limburg Genk and the University Hospital Antwerp/Queen Astrid Military Hospital Brussels, respectively.
About CyTuVax
CyTuVax was founded in Maastricht in 2012 by dr. René Vleugels and prof. dr. Frank W. Falkenberg. The company has developed a platform vaccination technology consisting of cytokines aggregates as powerful immune stimulators (adjuvant).
The technology has been initially designed for vaccination against cancer. The feature of CyTuVax’s adjuvant technology is the improved maturation of dendritic cell precursors at the site of injection and transport of cytokine-micro-aggregates directly into the lymph node. This allows CyTuVax’s adjuvant to be used in a wide range of vaccine concepts. Other products in development are the pancreas cancer vaccine PanCaVax and Cytomegalovirus (CMV) vaccine.
SOURCE: CyTuVax
                               

StephenW

CyTuVax开始其第2阶段的响应！研究

    类别：疫苗
    发布时间：2017年03月09日星期四19:18
    点击数：100

乙型无应答者的有效接种

MATETRICHT，荷兰I 2016年3月8日I CyTuVax是一家致力于开发新型疫苗的生命科学公司，今天报道开始了一项2期研究，评估其先导产品HBAI20（一种乙肝疫苗）的有效性和安全性。应答器。

无应答者是即使在用标准疫苗接受6次疫苗接种后也没有建立足够的免疫保护的人。 1期研究的结果显示，在90％的无反应者中，HBAI20疫苗诱导针对乙型肝炎的保护性免疫。该研究还显示，HBAI20疫苗的安全性和毒性特征与标准乙型肝炎疫苗相当。这个令人兴奋的结果现在将建立在BE RESPONDER！研究140非应答者。

HBAI20疫苗旨在满足需要针对乙型肝炎的保护效价的人群中未满足的医疗需求。百分之五的人群不能产生保护性水平的抗体滴度。这些无反应者不能防止乙型肝炎病毒感染，这可能导致慢性和致命的疾病。由于可能暴露于含有乙型肝炎病毒的体液，大多数处于感染乙型肝炎的风险是医护人员。也可受益的患者是移植受者，HIV，糖尿病和透析患者。

BE响应者！试验是一项双盲多中心国际临床试验，在3次或更多次乙型肝炎疫苗接种后招募无反应者。他们将接受HBAI20疫苗或标准乙型肝炎疫苗作为对照。 Astrid Oude Lashof博士，博士。 Geert Robaeys和教授。 Pierre van Damme将负责研究，分别负责马斯特里赫特大学医学中心，Ziekenhuis Oost Limburg Genk和大学医院安特卫普/阿斯特丽德皇后军医院布鲁塞尔的临床试验中心。

关于CyTuVax

CyTuVax在2012年由马斯特里赫特成立。 RenéVleugels和教授。 dr。弗兰克·法尔肯伯格。该公司已经开发了由细胞因子聚集体作为强大的免疫刺激剂（佐剂）组成的平台疫苗接种技术。

该技术最初设计用于针对癌症的疫苗接种。 CyTuVax的佐剂技术的特征是在注射和细胞因子 - 微聚集体直接运输到淋巴结的位点处的树突状细胞前体的改善的成熟。这使得CyTuVax的佐剂可用于广泛的疫苗概念。开发中的其他产品是胰腺癌疫苗PanCaVax和巨细胞病毒（CMV）疫苗。

来源：CyTuVax