质疑:最具前景艾滋疫苗数据分析不科学

【字体: 时间:2009年10月16日 来源:生物通

编辑推荐:

  生物通报道,几周前,由美国和泰国联合开发试验的新型艾滋病疫苗获得的结果“令人鼓舞”,这些消息来自临床试验的组织者,并未将相关文章发表在同行评审的期刊中,尤其是关于数据的处理以及分析依据等相关问题都没有详细披露。本周,The Scientist的一篇评论文章发表了对这结果的担忧。

  

生物通报道,几周前,由美国和泰国联合开发试验的新型艾滋病疫苗获得的结果“令人鼓舞”,这些消息来自临床试验的组织者,并未将相关文章发表在同行评审的期刊中,尤其是关于数据的处理以及分析依据等相关问题都没有详细披露。本周,The Scientist的一篇评论文章发表了对这结果的担忧。

 

事件背景

世界卫生组织和联合国艾滋病规划署924日发表联合声明表示,由美国和泰国联合开发试验的新型艾滋病疫苗获得的结果“令人鼓舞”。 声明说,这一代表重大科学进步的试验结果首次表明,通过疫苗是可以在普通成年人中预防感染艾滋病病毒的,其意义重大。新型艾滋疫苗可使人体感染艾滋病毒风险降低31.2% 这是研究人员在泰国选取1.6万多名志愿者经过6年测试后得出的结果。

 

质疑声起

The Scientist报道,有些科学家对这次艾滋病临床试验的公布的初步数据提出疑问,仅以前期的少部分数据来判断艾滋病疫苗试验的全局结果并不妥当。一个艾滋病研究中心提出:应该对这些数据进行独立的评估。

 

同时,据ScienceInsider报道,先前的报道称新型艾滋疫苗可使人体感染艾滋病毒风险降低31.2%,而对试验数据进行第二次分析却并没有得出相似的结论。

 

有科学家指出,新型的艾滋病疫苗的数据不具统计学意义。

 

NIH疫苗研究中心的专家Gary Nabel解释道,那是因为有些受试者没有接受完全的疫苗,这给数据分析产生了一些困难。怀疑者太过悲观而不相信这一疫苗的潜在能力。

 

参与新型艾滋疫苗研究的军方科学家Jerome Kim表示,他们将继续深入分析临床数据,并且打算将最清晰明朗的结果传递给民众。

 

有科学家表示,新型艾滋疫苗还只是个“早产儿”,目前不宜给太多的评论。

(生物通 小茜)

生物通推荐原文阅读

Hubbub brews for HIV vax data

 

With just a week left until the full results of the Thai HIV vaccine trial are released, researchers are raising questions about whether the preliminary data reported last month reveal but a small and misleading glimpse of the full study results. Meanwhile, a major AIDS healthcare provider this morning (October 12) called for an independent evaluation of the data.

 

Results of the $105 million HIV vaccination study, conducted in more than 16,000 Thai volunteers, showed that the vaccine decreased the risk of HIV infection by 31% compared to placebo. A second analysis not disclosed to the public, however, may negate these findings, ScienceInsider reported last week.

 

At issue is the inclusion of those subjects who did not rigorously follow the protocols of the study. An analysis in which these individuals were excluded still showed a modest benefit from the vaccine, but it is no longer statistically significant, according to AIDS researchers who have supposedly seen the unreleased data.

 

"The [initial analysis] includes many subjects who did not receive the complete vaccine (e.g. they did not complete the protocol) and so it introduces significant noise into the analysis," Gary Nabel of the National Institutes of Health's Vaccine Research Center (VRC) explained in an email to The Scientist in response to the ScienceInsider report. "As usual, there is some truth to both sides, but my feeling is that the skeptics are overly pessimistic and fail to recognize the potential value of this study."

 

Although both sets of data were available to the researchers at the time of the original announcement, they chose not to report them alongside the initial analysis, Jerome Kim, a US Army scientist who was involved in the study, told the Wall Street Journal. "We thought very hard about how to provide the clearest, most honest message," Kim said. "We stand by the fact that this is a vaccine with a modest protective effect." But some AIDS researchers (who preferred to remain anonymous) have suggested that the study leaders were dishonest and put a positive spin on a study with, at best, inconclusive results.

 

Others claim it's too early to say. "Since the data have not been formally presented in a scientific forum and are not publicly available," Barney Graham of the VRC wrote in an email to The Scientist, "I think it is premature to make any comments."

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