美疫苗公司Novavax埃博拉疫苗进入人体临床试验

美疫苗公司Novavax埃博拉疫苗进入人体临床试验

  发布日期：2015-02-13  来源：生物谷

近日，埃博拉疫情在西非又有抬头之势，各巨头正加速推进疫苗研发。Novavax在研疫苗也进入人体临床，其优势明显，如剂量小、可常规冷藏、多毒株靶向能力，有望最终胜出。

美国疫苗公司Novavax近日宣布，已启动实验性埃博拉疫苗Ebola GP Vaccine早期人体临床试验，目前该试验正在澳大利亚开展，涉及230名健康成人志愿者。研究中，每名志愿者将接受2针肌内注射，2次注射间隔21天，研究结果预计将在今年第二季度获得。

Novavax表示，该公司在研疫苗相对其他巨头的疫苗，具有明显优势，包括剂量小、常规冷藏、多毒株靶向能力，因此有信心能够在这场比赛中胜出，成为最有效的埃博拉疫苗。另外，目前该公司已掌握每月生产百万剂疫苗的技术，正在寻求资金以进一步推进。

根据世界卫生组织（WHO）最新公布的数字，此次在西非爆发的史上最严重埃博拉疫情，死亡人数已超过9000人。而疫情在近期又有了抬头之势，西非地区近2周新增病例再次增加。另外，本周美国总统奥巴马表示，随着埃博拉疫情的趋缓，将撤离大多数美军抗疫人员，而抗击疫情的努力也将转向由非军方领导的消灭埃博拉的行动。

当前，各大制药商正在积极寻求方法来预防和限制未来任何的疫情爆发。研究人员表示，要使埃博拉疫苗真正可行，应该具备的条件是价格便宜、易于生产及处理并方便运往非洲。而且，随着埃博拉毒株的不断演化，未来成功预防疫情爆发的关键将依赖于疫苗靶向多株病毒株的能力。

迄今为止，在埃博拉疫苗研发方面，英国制药巨头葛兰素史克（GSK）的临床推进是最快的，该公司的埃博拉疫苗即将进入III期临床阶段。其他几个巨头合作开发的疫苗尚处于较早期阶段，如默沙东（Merck & Co）正与Newlink Genetics合作开发一种埃博拉疫苗rVSV-EBOV，强生也与Bavarian Nordic达成合作开发另一种实验性疫苗。

强生此前表示，该公司研发的埃博拉疫苗将能够常规冷藏储存数周，而其他公司正研疫苗通常需保存在零下80摄氏度。Novavax则表示，与其他巨头在研疫苗相比，其埃博拉疫苗剂量相对要小，可以常规冷藏储存，而且具有靶向多株埃博拉毒株的潜力，因此在这场竞赛中最有希望胜出。

英文原文：Novavax starts Ebola vaccine trial in humans

* Study dataexpected by end of Q2 - CEO

* Co seekingfunding to further develop vaccine - CEO

* Vaccine haspotential to hit multiple strains - CEO

* Co says canmanufacture millions of doses a month (Adds CEO comment, detail)

By Natalie Grover

Feb 12 (Reuters) -Novavax Inc has begun early-stage human trials of an Ebola vaccine that ithopes can win the race to become the most effective shot for the deadly virus.

The company has themeans to manufacture millions of doses of the vaccine every month and isseeking funding to develop it further, Chief Executive Stanley Erck told Reuters.

The worst outbreakof Ebola on record has killed more than 9,000 people. After infection ratesshowed signs of stalling, the number of new cases has risen again in the lasttwo weeks.

Even as PresidentBarack Obama withdraws most U.S. troops fighting the epidemic in West Africa,drug developers are pursuing ways to prevent and limit any future outbreak.

For an Ebolavaccine to be viable, researchers say it must be cheap, easy to produce andcapable of being handled and transported to Africa. The future lies in theshot's ability to hit multiple strains as the virus evolves.

Novavax is testingits Ebola GP Vaccine in 230 healthy volunteers in Australia. Each subject, agedbetween 18 and 50, will receive two intramuscular injections 21 days apart.Results are expected by the end of the second quarter, Erck said.

Early human data ona vaccine being developed by GlaxoSmithKline Plc , the most advanced to date,has suggested a single dose may not provoke an immune response strong enough toprotect those exposed to Ebola.

Other drugmakersare collaborating to develop vaccines: Newlink Genetics Corp with Merck &Co Inc and Johnson & Johnson with Bavarian Nordic A/S.

J&J says itsvaccine can be stored at normal refrigerator temperature for weeks on end,giving it an advantage over test shots that are typically kept at temperaturesas low as minus 80 degrees Celsius.

Erck said Novavax'svaccine, which requires smaller doses than others in development, can also bestored at refrigerator temperatures and has the potential to hit multiplestrains of Ebola.

The company saidits human trial is backed by data showing that every animal vaccinated wasprotected from a lethal dose of the virus.

Shares ofGaithersburg, Maryland-based Novavax have risen more than 60 percent since Oct.27, when the company revealed it was testing its vaccine in non-human primates.

They were up 1.9percent at $8.40 on the Nasdaq on Thursday. (Editing by Saumyadeb Chakrabartyand Robin Paxton)

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