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People in AIDS vaccine study to be warned of poible higher risk
AIDS疫苗研究志愿者可能感染HIV的风险更高
Nearly 3,000 volunteers who participated in a study of an experimental AIDS vaccine that may have
unexpectedly raised the risk of contracting HIV will be notified shortly whether they received the actual vaccine or a placebo.意想不到的是参与AIDS疫苗研究的近3000名志愿者可能感染HIV,并将尽快告知他们是接受的真正的疫苗还是安慰剂。
Leaders of the study, including representatives of vaccine manufacturer Merck & Co., the National Institutes of Health, and a network of doctors who enrolled the volunteers decided Monday to “un-blind” it after lengthy discuions in Seattle last week.上周研究的领导人,包括疫苗生产商Merck公司的代表,国家
健康协会和志愿医师网络在西雅图经过长时间讨论后决定于周一将本事件公之于众。
Because the early results of the trial showed that vaccinated volunteers might be at higher risk of
contracting HIV, there was a compelling ethical case to tell participants whether they were aigned the vaccine or placebo.However, by un-blinding the study, researchers will be limiting the scientific value of any data produced as they follow participants in the coming years.因为早期的实验结果表明已接种疫苗的志愿者可能感染HIV的风险更高,告诉志愿者是否注射的是疫苗,还是安慰剂是一项刻不容缓的伦理使命。然而,将事情的真相公之于众之后,研究者在对志愿者随访中获得的数据就没有什么科学价值了。
“It's very important that we follow up with the study volunteers,” said Dr.Susan Buchbinder, director of HIV Research for the San Francisco Department of Public
Health, and co-chair of the committee that set up the protocols for the trial.San Francisco公共卫生HIV研究的主管,实验设计委员会主席Buchbinder说:“研究者的随访对我们来说非常重要。”
One hundred thirty-seven of the trial participants live in the Bay Area.37%的受试者居住在海湾地区。
Although the study showed definitively that the
vaccine did not protect against HIV infection, the early trend showing increased risk among the vaccinated was not proven.So far, 49 of the 1,500 volunteers who received the vaccine have become infected, compared with 33 among a similarly sized group given a placebo.虽然最后的研究表明疫苗不能预防感染HIV,但是可能增加感染风险的早期趋势并没有得到证实。目前为止1500个接受疫苗者中有49人感染,而与之对应的安慰剂组中也有33人感染。
In addition, 21 of those infected in the vaccinated group also tested positive for prior exposure to a
common cold virus, which was used in hobbled form as a component of the vaccine.Only nine of those in the placebo group who showed prior exposure to the cold virus were infected.此外,注射疫苗组中的21个感染者在之前的普通冷病毒暴露实验中呈阳性,冷病毒是该疫苗的载体成分。安慰剂组冷病毒暴露实验阳性者中只有9人感染了HIV。
Buchbinder said researchers don't know why the vaccinated group had an apparently higher infection rate, but one poibility is simply chance-and that over time, the number of infections in both groups would level out.Buchbinder说研究者不知道为什么疫苗注射组的感染率较高,但是其中一种可能原因就是偶然性,并且随着时间的推移两组的感染率将会持平。
The San Francisco AIDS physician said she agrees with the decision to un-blind the study.“At the meeting in Seattle on Thursday, there was lots of opportunity for discuion among the investigators and the
community, and the vast majority were in favor of un-blinding,” she said.旧金山艾滋病中心的医生说,她同意揭晓研究的真相的决定。她说:“星期四在西雅图的会议上,研究者和公众讨论了多种可能方案,但是绝大多数人还是主张揭开事情的真相。
The alternative would have been to allow any participants to be told whether they received the vaccine if they asked to know, but many researchers concluded that there would be little extra information gained by this strategy of “voluntary un-blinding.” 这一抉择表示如果志愿者想知道自己是否注射了疫苗的话,研究者应该告知。但是很多研究者推断“告知志愿者”的决策使他们只能获得较少的信息。