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赛诺菲登革热疫苗关键III期疗效研究达主要终点

2014年4月28日讯 /生物谷BIOON/ --法国制药巨头赛诺菲(Sanofi)旗下疫苗事业部赛诺菲巴斯德(Sanofi Pasteur)4月28日宣布,登革热候选疫苗2个关键III期疗效研究中的首个研究达到了主要临床终点。该研究表明,候选疫苗将登革热病例显著降低56%。该项研究数据的全面分析将在未来几周内开展,并交由外部专家组审查,之后会在即将到来的国际科学会议公布。

登革热(Dengue)是一种蚊媒疾病,俗称"断骨热(breakbone fever)",威胁着全球近30亿人,该病在亚洲和拉丁美洲流行。世界卫生组织(WHO)预计,每年有超过1亿人感染登革热。登革热往往由于轻度非特异性至危及生命并发症的大范围临床症状而误诊,同时监控系统的局限性也是导致登革热病例报道不足的原因。在全球范围内,每年有50万人(包括儿童)患上登革出血热(DHF)。及时获得恰当的医疗护理对于降低严重登革热死亡风险至关重要。WHO已设定目标,到2020年,将登革热死亡率降低50%,发病率降低25%。目前,登革热出血热尚未有任何针对性治疗药物。登革热由4种不同血清型的登革热病毒引发,各病毒株之间不会产生免疫作用,所以可以被不同的血清型登革病毒重复感染。

该项研究中,对照组观察到的年发病率高达4.7%,表明登革热在亚洲是一种非常高的疾病负担。菲律宾热带医学研究所首席研究员Capeding博士评价称,这是有史以来首次一种登革热疫苗成功完成III期疗效研究。这些重要的临床数据,以及疫苗良好安全性的相关数据,将为每年受登革热感染超过1亿的群体带来真正的希望。

目前,在拉丁美洲正在开展第2项大规模III期疗效研究,涉及超过2万名志愿者,这些志愿者来自巴西、哥伦比亚、洪都拉斯、墨西哥、波多黎各。该项研究的数据,将于2014第三季度获得。

关于亚洲III期疗效研究

在亚洲开展的III期疗效研究,是一项随机、观察者双盲、安慰剂对照、多中心临床研究,总计有10275名2-14岁儿童参与了2011-2013年,这些儿童均来自亚洲国家(印尼、马来西亚、菲律宾、泰国、越南)的登革热流行地区。研究中,志愿者随机(2:1)接受3剂登革热疫苗或安慰剂(每6个月注射1剂)。主要终点通过由任何血清型引发的对症病毒学确诊的登革热病例数量来衡量。该项研究将继续对志愿者进行长期随访。

关于登革热疫苗临床项目

赛诺菲巴斯德致力于登革热疫苗开发超过20年,该公司的目标是,为全球所有地区提供一种安全有效的登革热疫苗。

有超过4万名志愿者参与了该公司的登革热疫苗临床研究项目(I期、II期和III期)。目前,登革热疫苗已处于III期临床,该疫苗是临床上和业界最先进的登革热候选疫苗,同时也是首个处于后期开发的登革热疫苗。

2项关键性III期疗效研究,涉及来自亚洲(印尼、马来西亚、菲律宾、泰国、越南)和拉丁美洲(巴西、哥伦比亚、洪都拉斯、墨西哥、波多黎各)的超过3.1万名志愿者。这些III期研究,将提供登革热疫苗在广泛人群和不同流行病学环境中疗效、安全性、免疫原性,同时将评估该疫苗对疾病负担的潜在影响。(生物谷Bioon.com)

英文原文:Sanofi successfully completes dengue vaccine study

THE WORLD'S FIRST, LARGE-SCALE DENGUE VACCINE EFFICACY STUDY SUCCESSFULLY ACHIEVED ITS PRIMARY CLINICAL ENDPOINT

The World's First, Large-Scale Dengue Vaccine Efficacy Study Successfully Achieved Its Primary Clinical Endpoint

First available data demonstrated a 56% reduction of dengue disease cases in
 a study of more than 10,000 volunteers from Asia
 
Initial safety data are consistent with the good safety profile observed in previous studies

Lyon, France - April 28, 2014 - Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), today announced that the first of two pivotal Phase III efficacy studies with its dengue vaccine candidate has achieved its primary clinical endpoint. The efficacy study showed a significant reduction of 56% of dengue disease cases. Initial safety data are consistent with the good safety profile observed in previous studies. Full analysis of the data will be undertaken in the coming weeks and reviewed by external experts prior to disclosure at an upcoming international scientific congress and publication in a peer-reviewed journal later this year.

Dengue is a threat to nearly half the world's population1, 2 and is a pressing public health priority in many countries in Asia and Latin America where epidemics occur. The annual incidence rate of 4.7% observed in the control group demonstrates the very high burden of disease in Asia.
 "This achievement is the result of more than 20 years of work in the field of dengue, collaborating with investigators, volunteers, authorities, scientific experts and international organizations," said Olivier Charmeil, President and CEO of Sanofi Pasteur. "Developing a dengue vaccine for the benefit of children and their parents is at the heart of our mission. Our goal is to make dengue the next vaccine-preventable disease and to support the WHO's ambition to reduce dengue mortality by 50% and morbidity by 25% by 2020."

"This is the first time ever a dengue vaccine successfully completed a Phase III efficacy study," said Dr. Capeding, principal investigator, Research Institute for Tropical Medicine, the Philippines. "These significant clinical results, associated with the good safety profile of the vaccine, bring real hope to more than 100 million people affected each year by dengue, a disease without any specific treatment today." 

The results of this first, large-scale efficacy study will be further complemented by results in Q3 2014 from a second, large-scale study currently conducted in Latin America, including more than 20,000 volunteers from Brazil, Colombia, Honduras, Mexico and Puerto Rico.

About the Phase III clinical study conducted in Asia
The Phase III clinical study conducted in Asia is a randomized, observer-blind, placebo-controlled multicenter trial. A total of 10,275 children aged 2 to 14 years from dengue endemic areas of Indonesia, Malaysia, the Philippines, Thailand and Vietnam participated in the study from 2011-2013 and were randomized to either receive three injections of the dengue vaccine or a placebo (2 to 1 ratio) at 6-month intervals. The primary endpoint was measured by the number of symptomatic virologically-confirmed dengue cases caused by any serotype. The study will continue with a long term follow up of the population.

About Sanofi Pasteur's dengue vaccine clinical program
Sanofi Pasteur has been working on a dengue vaccine for more than 20 years. The company's goal is to provide a safe and effective dengue vaccine accessible in all regions of the world where dengue is a public health issue.

Over 40,000 volunteers are participating in the Sanofi Pasteur dengue vaccine clinical study program (Phase I, II and III). Sanofi Pasteur's dengue vaccine candidate is in Phase III clinical studies. It is the most clinically and industrially advanced vaccine candidate in development and the first dengue vaccine in advance development.

The two, pivotal Phase III efficacy studies involve more than 31,000 volunteers from Asia (Indonesia, Malaysia, the Philippines, Thailand and Vietnam) and Latin America (Brazil, Columbia, Honduras, Mexico and Puerto Rico). The Phase III evaluations provide pivotal data on efficacy, safety, and immunogenicity of the vaccine candidate in a broad population and different epidemiological environments and assess the potential impact of the vaccine on the disease burden.

About Dengue
Dengue is a threat to nearly half of the world's population. Currently, there is no specific treatment available for dengue. It is a health priority in many countries of Latin America and Asia where epidemics occur regularly. The WHO estimates up to 100 million infections per year but the overall number of people infected with dengue globally is not fully known.1 The WHO has set the goal of estimating the true public health burden of dengue by 2015.2 Dengue is underreported because the disease is often misdiagnosed due to a large spectrum of clinical symptoms from mild non-specific illness to life threatening complications and because of the limitations of the surveillance systems.

Each year, 500,000 people, including children, are affected with dengue hemorrhagic fever (DHF), the severe form of the disease. DHF is a leading cause of hospitalization, placing tremendous pressure on health systems and straining medical resources resulting in significant economic and social impact. Timely access to appropriate health care is critical to reduce the risk of mortality in case of severe dengue. The WHO has set the target to reduce dengue mortality by 50% and reduce morbidity by 25% by 2020.

关键词:赛诺菲,登革热,疫苗

信息来源:生物谷