2014年12月4日讯 /生物谷BIOON/ --根据瑞士研究人员周二公布的消息，截至目前为止，由默沙东和NewLink合作开发的一种实验性埃博拉疫苗VSV-ZEBOV，在临床试验中接种的首批志愿者，未发生严重副作用，仅有少数经历轻度发热。
继葛兰素史克（GSK）和强生（JNJ）之后，上周疫苗巨头默沙东与NewLink达成合作，也加入了埃博拉疫苗研发阵营。双方将联手开发实验性疫苗VSV-ZEBOV，该疫苗采用了一种有缺陷的、能够感染家畜的水泡性口炎病毒，将病毒的一种基因用埃博拉病毒的基因替换。根据协议，默沙东支付5000万美元获得VSV-ZEBOV及任何后续产品的商业化权利。
目前，VSV-ZEBOV正在瑞士日内瓦大学医院开展人体安全试验，是数个被迅速推进至临床试验的埃博拉疫苗之一。瑞士研究人员指出，自11月10日到现在，已有34例志愿者接种疫苗。每个志愿者接种疫苗后被留院观察1.5小时；截至目前，尚未发生严重副作用，少数志愿者经历了轻度发热。这也是VSV-ZEBOV疫苗的首批临床数据。此外，VSV-ZEBOV在美国、加拿大、德国、非洲加蓬共和国的临床试验已经启动，同时即将在肯尼亚启动类似临床试验。
上周，葛兰素史克（GSK）研发的实验性双价埃博拉疫苗顺利通过I期临床安全性试验，疫苗耐受性良好，并在全部20例健康成人志愿者中诱导了免疫反应，高剂量疫苗诱导的免疫反应与动物实验中所诱导的对抗埃博拉感染的免疫反应相媲美。该疫苗利用黑猩猩腺病毒3型（ChAd3）感冒病毒作为载体，将2株埃博拉病毒（苏丹株和扎伊尔株）的遗传物质递送至体内。该公司开发的另一种针对扎伊尔株（Zaire strain）的单价埃博拉疫苗，目前正在英国、马里、瑞士开展安全性试验，扎伊尔株导致了当前的埃博拉疫情。而强生（JNJ）的埃博拉疫苗预计将于2015年1月进入临床试验。
根据世界卫生组织（WHO），此次埃博拉疫情是有史以来最大的一次，迄今感染人数超过1.6万例，死亡人数近6000例，绝大多数感染和死亡病例发生在几内亚、塞拉利昂和利比里亚。一些埃博拉病毒专家表示，如果没有疫苗，埃博拉疫情不大可能得到控制。
英文原文：No serious side effects in Merck/Newlink Ebola vaccine test
LONDON, Dec 2 (Reuters) - The first people vaccinated with an experimental Ebola shot being developed by Merck and NewLink have had no serious side effects so far, but a few experienced mild fever, Swiss researchers said on Tuesday.
The shot, one of several being fast-tracked through clinical trials in the hope they can be approved for use in the Ebola epidemic raging in West Africa, is undergoing initial human safety tests at the University Hospitals of Geneva.
"After his or her injection, each volunteer was kept under observation for 1.5 hours at the clinical trials unit," scientists at the Swiss hospital said in a statement.
"To date, no major side effects have been observed after the injections, which triggered the expected inflammatory responses. They (the inflammatory responses) have been weak to moderate, with limited cases of mild fever," it added.
Since 10 November, 34 volunteers have been vaccinated with the shot, known as VSV-ZEBOV Ebola vaccine, at the request of the World Health Organization (WHO).
Trials have also begun in the United States, Canada, Germany and Gabon, and similar trials should start soon in Kenya.
This is the first data from human testing of the Merck/Newlink shot. It follows positive news last week about a GlaxoSmithKline candidate Ebola vaccine, which caused no serious side effects and produced an immune response in 20 volunteers in early-stage trials.
A version of GSK's vaccine targeting only the Zaire strain of Ebola which is causing the current outbreak is undergoing safety trials in Britain, Mali and Switzerland.
A trial of an Ebola vaccine from Johnson & Johnson is scheduled to start in January.
The Ebola epidemic is the largest ever recorded and has so far infected around 16,000 people, killing almost 6,000 of them, according to latest WHO figures. The vast majority of cases and deaths have been in Guinea, Sierra Leone and Liberia.
Some Ebola experts say it is unlikely the epidemic can be brought under control without the use of a vaccine, which if successful could protect healthy people from being infected with the contagious and deadly virus.
Merck announced last month that it would buy the rights to NewLink's vaccine for $50 million.