2009年9月24日星期四

【China AIDS:4753】 《卫报》能预防艾滋病毒感染的新疫苗或将面世

能预防艾滋病毒感染的新疫苗或将面世

在泰国进行的一项由美国军方支持的医疗试验发现,某实验性疫苗能将感染艾滋病毒的风险减少三分之一。
     

Sarah Boseley and Haroon Siddique
guardian.co.uk   2009年09月24日


iDo98 @ yeeyan 翻译    原文链接

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   本栏目文章的英语原文均首先发表于卫报或其周日出版的姊妹报--观察家。卫报于1821年创办于曼彻斯特,是一家独立的英国报纸,并被广泛认为是国际新闻、环保、科技、媒体与文化等领域的重要信息来源。卫报与翻译社区译言合作,共同将部分优秀内容献给中国读者。

艾滋病毒的显微图像。


科学家宣布,一种实验性疫苗令感染艾滋病毒的风险减低了三分之一。在泰国进行的这项医疗试验唤起了公众寄予对抗艾滋病取得重大突破的希望。

据美国陆军透露,这项由美国陆军与美国国家过敏症及传染病研究所(National Institute of Allergy and Infectious Diseases)一同赞助的艾滋病疫苗测试,堪称全球历来规模最大的一次。他们对16000多名志愿者进行了测试,结果首次出现成功预防艾滋病毒感染的案例。

接受测试的志愿者都是年龄介于18岁至30岁、艾滋病毒抗体检测呈阴性、受感染风险为中等的泰国男性和女性。所有的志愿者接受咨询,并配发避孕套,以帮助他们避免感染艾滋病。然后,随机选择一半志愿者接受两种疫苗组合注射的测试,而另一半志愿者接受安慰剂的注射。直到试验结束,没人知道哪个志愿者是属于其中哪个小组的。

结果相对较少的志愿者感染上艾滋病毒,其中在接受疫苗注射的8197名参与者中,感染艾滋病毒的有51人;在接受安慰剂注射的8198名参与者中,感染艾滋病毒的有74 人。但是两者之间的差异具有统计学意义,这也就是说,科学家确信这个差异不是由于偶然因素引起的。经计算得出的结论是,对于接受疫苗的那一组志愿者来说,艾滋病毒感染风险降低了31%。

美国陆军负责领导这项耗资达1.05亿美元(合6400万英镑)研究的杰罗姆·金(Jerome Kim)上校说,这是"我们可以研发出一种安全有效的艾滋病毒预防性疫苗的首个证据。"

最近一系列研制艾滋病毒预防性疫苗的试验接连失败,致使许多科学家认为这种疫苗可能无法实现。在2007年,默克制药公司(Merk)在试验结果令人失望之后,放弃了当时看似最有前途的研究项目。美国国家过敏症及传染病研究所所长安东尼·福西(Anthony Fauci)博士警告说,这"不是研发之路的终极目标",但也对试验结果表示惊讶,而且也深感满意。

"这让我对改善这个试验结果怀有谨慎乐观的态度,"他说:"这是我们可以做到的。"

每天,全世界有7000名新艾滋病患者;据联合国艾滋病规划署(Unaids)的估计,在2007年,全世界共有2万人死于艾滋病。

一直以来在研发相关疫苗的国际组织——美国艾滋病疫苗倡导联盟(Aids Vaccine Advocacy Coalition)对这项自1983年以来的第三次重大研究的试验结果表示欢迎。"一个历史性的里程碑"的事件是:人类免疫缺陷病毒(HIV,又称艾滋病毒)于1983年被确认为艾滋病的致病原因。

美国艾滋病疫苗倡导联盟的执行理事米切尔·沃伦(Mitchell Warren)说:"毫无疑问,这一试验结果将在艾滋病疫苗领域中发挥激励的作用,并重新定位艾滋病疫苗的研发方向。"

英国帝国理工学院的免疫学教授弗朗西斯·高驰(Frances Gotch)表示,这项研究结果似乎有统计学意义,可能是两种不同的疫苗的协同作用,从而产生更为强大的效果。

高驰也是国际艾滋病疫苗行动组织(International Aids Vaccine Initiative)的首席调查员,他在接受《卫报》记者采访时说:"使用疫苗后,艾滋病毒感染发生率如此之低,实在令人印象深刻。"

"当然不是人们得到了100%的(保护),但降低了31%的风险或许就能让世界大为不同。我觉得这是我们可以接受的。"

泰国公共卫生部进行了这项针对泰国常见艾滋病毒菌株的研究。

科学家强调说,他们并不知道这种疫苗是否能够预防世界其他地方出现的艾滋病毒菌株。该项研究之所以选择在泰国进行,是因为美国陆军的科学家在泰国出现艾滋病流行时,曾在泰国进行了关键性研究,对病毒菌株进行分离,并且向疫苗生产商提供这些艾滋病毒菌株的遗传信息。

这项研究测试了两种疫苗的组合注射,采用"启动—提高"的办法,其中第一种疫苗启动免疫系统攻击艾滋病毒,而第二种疫苗则强化这一反应。

艾滋病毒疫苗Alvac使用一种称为金丝雀痘病毒(canarypox)的禽流感病毒,对该病毒进行改变使它不能引起人体疾病,将三种艾滋病毒基因一同载入体内。 而艾滋病毒疫苗Aidsvax则含有艾滋病毒表面的经基因工程改造过的某种蛋白。

目前尚不清楚疫苗制造商是否会寻求获得在泰国生产销售这种双疫苗组合的许可权。在这项试验开始之前,美国食品和药物管理局(US Food and Drug Administration)曾指出,在考虑颁发这种双疫苗的美国许可权之前,还需进行一些其他相关的研究。这一试验的全部结果将于10月份在巴黎召开的国际艾滋病疫苗会议上公布于众。

研究机构及资助机构(比如盖茨基金会)联盟组织——全球艾滋病疫苗企业计划(Global HIV Vaccine Enterprise)的执行董事阿兰·伯恩斯坦(Alan Bernstein)表示,这项研究的结果显示,研发艾滋病毒疫苗是一个可以实现的目标。 "这是寻求研制艾滋病疫苗的26年来最具历史性的一天,"伯恩斯坦博士说,"这项试验首次证明了,人类通过更多的研究,将会有可能研制出一种完全可以预防艾滋病毒的疫苗。"

英国的全国爱滋信托基金会总裁德博拉·杰克(Deborah Jack)表示,目前,迫切需要艾滋病毒疫苗,因为疫苗是迄今为止治疗重大传染性疾病的最有效方法。还需进行更多的研究工作,但这个颇有希望的结果"验证了一点,那就是包括英国政府在内的国际社会继续投资并致力于研制艾滋病毒疫苗是完全合适的。"

英国主要的艾滋病慈善机构——特伦斯希金斯信托组织(Terrance Higgins Trust)表示对此研究结果持"谨慎乐观"的态度。

该组织的政策经理维姬·希尔德(Vicky Sheard)说:"这是在漫漫长路上跨出的第一步。"

"对于疫苗的推出、所需付出的昂贵费用以及是否对不同艾滋病毒菌株也有效等方面,还需进行许多研究。"

HIV breakthrough as scientists discover new vaccine to prevent infection

First evidence of possible vaccine as US military-backed medical trial in Thailand cuts HIV infection rate by a third

A scanning electron microscopic image of HIV

A microscopic image of the HIV virus.

A medical trial in Thailand has raised hopes of a major breakthrough in the fight against Aids after scientists said an experimental vaccine had reduced the risk of HIV infection by a third.

The world's largest HIV/Aids vaccine trial of more than 16,000 volunteers was the first in which infection has been prevented, according to the US army, which sponsored the trial with the National Institute of Allergy and Infectious Diseases.

A combination of two vaccines was tested on HIV-negative Thai men and women aged 18 to 30 at average risk of becoming infected. All the volunteers were given counselling and condoms to help them avoid HIV. Then half were randomly picked to receive the vaccine, while the other half got dummy shots. Until the trial ended, nobody knew who had been given the genuine vaccine and who had not.

A relatively small number of people became infected with HIV – 51 of the 8,197 people given the vaccine, and 74 of the 8,198 who received dummy shots – but the difference was statistically significant, which means scientists believe it could not have happened by chance. It worked out at a 31% lower risk of infection for the vaccine group.

Colonel Jerome Kim, who helped to lead the $105m (£64m) study for the US army, said it was "the first evidence that we could have a safe and effective preventive vaccine".

Recent failures had led many scientists to believe that such a vaccine might not be achievable. In 2007, the drug company Merck abandoned what had looked at the time like the most promising avenue of research after disappointing trial results. Today the National Institute's director, Dr Anthony Fauci, warned it was "not the end of the road", but said he was surprised and very pleased by the outcome.

"It gives me cautious optimism about the possibility of improving this result," he said. "This is something that we can do."

Every day, 7,000 people worldwide are newly infected with HIV; 2 million died of Aids in 2007, the UN agency Unaids estimates.

The Aids Vaccine Advocacy Coalition, an international group that has worked towards developing a vaccine, welcomed the results of the trial – the third major study since 1983, when HIV was identified as the cause of Aids – as "a historic milestone".

The executive director, Mitchell Warren, said: "There is little doubt that this finding will energise and redirect the Aids vaccine field."

Frances Gotch, professor of immunology at Imperial College London, said the results appeared to be statistically significant and may have been the effect of the two different vaccines working in tandem to more powerful effect.

"The fact that they have seen a response with people with such a low incidence of infection is impressive," Gotch, who is also the principal investigator for the International Aids Vaccine Initiative, told the Guardian.

"Of course it's not 100% of people [protected] but 31% could make an enormous difference in the world. I think this is something we can work with."

Thailand's ministry of public health conducted the study, which used strains of HIV common in Thailand.

Scientists stressed it was not known whether such a vaccine would work against other strains elsewhere in the world. The study was done in Thailand because US army scientists carried out pivotal research in that country when the Aids epidemic emerged there, isolating virus strains and providing genetic information on them to vaccine makers.

The study tested a two-vaccine combination in a "prime-boost" approach, where the first one primes the immune system to attack the HIV virus, and the second one strengthens the response.

Alvac uses canarypox, a bird virus, altered so it can't cause human disease, to ferry synthetic versions of three HIV genes into the body. AidsVax contains a genetically engineered version of a protein on HIV's surface.

It is unclear whether vaccine makers will seek to license the two-vaccine combination in Thailand. Before the trial began, the US Food and Drug Administration said other studies would be needed before the vaccine could be considered for US licensing. The full results of the trial will be presented at an international Aids vaccine conference in Paris in October.

The executive director of the Global HIV Vaccine Enterprise, an alliance of research bodies and funders like the Gates Foundation, said the results showed a vaccine was an achievable goal. "This is a historic day in the 26-year quest to develop an Aids vaccine," said Dr Alan Bernstein. "This trial is the first demonstration in humans that, with more research, it will be possible to develop a vaccine that is fully protective against HIV."

Deborah Jack, chief executive of the National Aids Trust in the UK, said a vaccine, by far the most effective way of tackling serious infectious diseases, was desperately needed. More work was needed, but the promising findings "justify the continuing investments and efforts of the international community, including the UK government, to develop a vaccine."

The Terrence Higgins Trust said it was treating the results with "cautious optimism".

"This is the first step on a very long road," said the policy manager, Vicky Sheard.

"There's a lot of research needed into how a vaccine can be rolled out, how costly it's going to be, whether it's going to be effective against different strains."



--
常坤 Chang Kun

为艾滋病防治努力一生!
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★中国艾滋病博物馆/China AIDS Museum: http://www.AIDSmuseum.cn
    旗下网站:
——艾博维客 AIDS Wiki : http://www.AIDSwiki.cn
——艾博聚合(汇聚艾滋病博客)http://www.wanyanhai.org
——中国艾滋病网络:http://www.ChinaAIDSgroup.org
——中国艾滋病地图/China AIDS Map:http://www.AIDSmaps.org
——空腹健身运动:http://www.HungerStrikeforAIDS.org
——艾滋人权 AIDS Rights:  http://www.AIDSrights.net
——常坤:为艾滋病防治努力一生:Http://www.changkun.org
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